IPP REVENUE HITS

Wednesday, October 31, 2012

Wholesale for Nalbuphine?

If you are looking for wholesaler of Nalbuphine HCl, specifically for Nubain, you can go directly to Invida Philippines, who markets the product here in Philippines. They can give up to 15% discount depending on the quantity you will procure. Nubain can be availed in 10mg/ml ampoule in hundred pieces per box. The regular price offer for Nubain in the Philippines is PhP11,769.00 per box. But you can talk to the salesman if he can still give you higher discounts for small scale purchases. Invida Philippines partnered with Zuellig Pharma, as their solely distributor, to distribute and deliver their products to customers, thus, you should have a Zuellig Pharma account before they can serve you. Another thing in procuring Nubain, you should have at least S-license from Philippine Drug Enforcement Agency (PDEA) to licitly transfer any dangerous drug, especially Nalbuphine ampoules.

In my case, the pharmacy I am working at has Zuellig Pharma account, registered in PDEA for S3 license and availing up to 28% discount for only purchasing of four boxes, that brings great discounts and profit to earn for us. But you can procure Nalbuphine HCl ampoules in subdistributors, they should be legally registered to comply to provisions, and to avoid punishments and penalties before transaction is taken up. To know better about their S-license's status, you can inquire or call PDEA hotlines for more details.

Pharmaceutical Quality Control Calculations A2

STABILITY COMPUTATION

Formulation:
Active 1: 65 mg (limits 95-105%)
Active 2: 15 mg (limits 90-110%)
Active 3: 122 mg (limits 90-110%)

Results of Analysis:




Questions:
1. Determine the minimum and maximum limits of each active based on the specifications:
  • Active 1
  • Active 2
  • Active 3
2. What is the shelf-life of the formulation?
A) 24mos
B) 12 mos
C) 36 mos
D) 48 mos
E) 6 mos

3. What would be the expiry date of a product manufactured on October 30, 2012?
A) October 30, 2013
B) October 30, 2014
C) October 30, 2015
D) October 30, 2016
E) October 30, 2017

Answers and Solutions

Phytochemical Screening

Phytochemical Screening or Preliminary Test is the first thing to be done before major discoveries of molecules or drug entities are known. It is used to provide concrete knowledge and research to what plant active constituents have potential to benefit mankind.

Materials to needed:

100g of plant sample                                                     0.5N Potassium Hydroxide
80% or 95% ethyl alcohol                                             Diluted Hydrogen Peroxide (5%)
Mayer's reagent                                                            Glacial Acetic Acid
Wagner's reagent                                                          10% NaOH Solution
Gogo extract (10%)                                                      Water Bath
5% Sodium Carbonate                                                  Solution Benzene or Chloroform
1% Ferric Chloride                                                        Solution Octyl Alcohol
10% Sodium Chloride                                                   Solution Petroleum Ether or Hexane
2M Hydrochloric Acid                                                  Separatory Funnel
1N Sodium Hydroxide                                                  Magnesium Oxide
Magnesium Turnings                                                      Kedde Reagent
1% Gelatin                                                                    Concentrated Sulfuric Acid
Gelatin Salt Reagent                                                      Anhydrous Sodium Sulfate
Ferric Chloride Reagent                                                Acetic Anhydride
Sodium Picrate paper                                                    Ammonia Solution

A. Preparation of Extact
Weigh the ground dried plant material, about 100 grams, in an Erlenmeyer Flask, and treat with sufficient amount of 80% ethyl alcohol to completely submerge the material. Note the volume of alcohol used. Put a stopper on the flask and keep the material soaked for one to two days. The mixture will be filtered, rinsing the remaining material on the flask with fresh alcohol, is to be filtered again and added to the first filtrate, this must be done to provide accurate extraction. Collect the plant extract and discard the plant residue. Concentrate the filtrate to about 20ml. Measure the exact volume of the concentrated extract. Record the concentration of the stock plant extract as grams of dried plant material per ml of the extract obtained. Store the extract tightly closed, preferably in the cold condition (0-5 C).
Note: Concentrated extracts should be stored with a trace of toluene or chloroform to prevent fugal growth if kept at room temperature.
  • Data and Calculation:

    Weight of the beaker
    Weight of the beaker + plant sample
    Weight of the plant sample
    Volume of the extract
    Equivalent of plant material per ml of the extact

Equivalent of plant material / ml   =    Weight of Sample
                                                              Volume of Sample


B. Test for Alkaloids

Preliminary Test

Take an equivalent of 2.0grams of stock plant extract. Evaporate to a syrupy consistency over a steam bath. Add 5ml of 2M HCl and heat while stirring for 5 minute then cool. Add about 0.5 g Sodium Chloride, stir and filter. Wash the residue with enough 2M HCl to bring the filtrate to a volume of about 5ml. Place 1ml each of the filtrate to two test tubes and test as follows:

a) One ml of the filtrate add a few drops of Mayer's Reagent.
(+) result is formation of turbid or white precipitate that indicates the presence of alkaloids.

b) One ml is to be added a few drops of Wagner's Reagent.
(+) result is reddish brown colored precipitate indicates the presence of alkaloids

Record the relative amount of precipitation observed as follows:
(+) Slight Turbidity
(++) Definite Turbidity
(+++) Heavy Precipitation

Confirmatory Test

To the remaining three ml of the filtrate, add dropwise enough 28% ammonia until the solution is alkaline to the litmus. Extract the alkaline solution three time with addition of ten ml portions of chloroform. Combine the lower chloroform extracts and reserve the upper aqueous layer. (The alkaline layer is reserved for the test for quaternary and/or amine oxide bases). Evaporate the chloroform extracts until it dries, under the hood and over a steam bath. Take up the residue with 5ml of 2M HCl, stir over a steam bath for two minutes and cool. Filter and divide filtrate into two equal portions and test as in Preliminary test. Positive results indicate the presence of secondary or tertiary alkaloids.

Test for Quaternary and amine oxide bases

Acidify the alkaline aqueous layer obtained above with 2M HCl. Filter and divide into two parts, then use the confirmatory test for alkaloids. A positive results will show that quaternary or amine oxide molecules are present. But a positive result will be resulted when incomplete chloroform extraction is done, thus, should be considered negative for quaternary bases.

C. Test for Saponin Gyclocides

Froth Test

Take an amount of the alcohol extract equivalent to two grams plant material and transfer this to a test tube. In a separate test tube, have one ml of gogo extract to use as a control or standard. Add 10ml of distilled water to each of the test tubes, close tightly and shake both test tubes vigorously for thirty seconds. Stand for thirty minute then observe for a “honeycomb froth”. Compare result of extact with the standard.

(+) result is persistent froth (1 cm height)was observed for 1 hr. indicates the presence of saponins.

Hemolytic Test

Obtain a blood agar plate. Scoop three minicup from blood agar from three areas of the plate with equidistant from one another using the small test tube. Number each agar cup at the bottom of the inverted plate with a marking pen. With a small pipette, put enough extract to one of the agar cups to fill it. Fill the second with the same volume of gogo extract as positive control. Add the last cup with distilled water as negative control. Allow the the plate to be covered and stood undisturbed. After an hour, observer the agar for any zone clearing with the three agar cups. Mesure the diameter of the halo in millimeter.

(+) result is a homolytic zone is observed with the control and the plant extract due to rupture of red blood cells.

Procedure for removing interfering tannins and other plant polyphenolic compounds

Take a volume of the plant extract equivalent to ten grams plant material and evaporate this to incipient dryness over a steam bath. Extract the residue with twenty ml of hot distilled water. Add five drops of 10% Sodium Chloride solution and filter. Subject the saline filtrate with two grams of magnesium oxide to form a slurry and heat over a steam bath for about 10 minutes. Extract the slurry with hot 80% ethanol, then filter. Subject the detannated aqueous ethanol filtrate to the hemolytic test.

Liebermann-Burchard Test

Evaporate an equivalent of ten grams of plant extract until dryness using a water bath. Add about ten ml of hexane or petroleum ether to the cool residue. Stir for a few minutes, allowing to settle and decant off the supernatant. Repeat until all the color has been removed. To the residue, add about ten ml of chloroform and stir for five minutes. Decant into a test tube containing about 100mg of Anhydrous Sodium Sulfate. Shake and filter, dividing the filtrate into two clean dry test tubes. To one portion, add three drops of Acetic Anhydride. Mix gently. Then add one drop of Concentrated Sulfuric Acid, mixing it gently. Observe color changes immediately over a period of one hour. Use other test tube as reference.

(+)  results is reddish violet colour at the junction of the two layers and a bluish green colour in the Acetic Anhydride layer indicates the presence of unsaturated sterols and or/triterpenes.

D. Test for Cardenolides and Bufadienolides

Keller-killiani Test

Have an 80% alcohol extract equivalent to ten grams of plant. Evaporate until dryness over a water bath. Defat extraction by trituration with hexane to remove as much of the color pigments as possible. Discard the hexane solution. Warm the defatted residue over a water bath to remove the residual hexane solvent. Add three ml of FeCl Reagent. Stir to mix well and transfer to a test tube. Hold the test tube in an slant position, and carefully add an ml of Concentrated Sulfuric Acid that allows the acid to roll inside the walls of the test tube. Allow the mixture to stand for a while. Determine any change of color in the junction.

(+) result is presence of reddish brown color which may gradually become bluish or purplish color indicate the presence of two deoxysugars.

Salkwoski Test

Evaporate the equivalent of ten grams of plant extract to dryness using a bath water. Addition of about ten ml hexane or petroleum ether to the cool residue. Stir for a few minutes allowing to settle and decant off the supernatant. Repeat until all the color has been removed. To the residue add about ten ml of Chloroform and stir for five minutes. Decant into a test containing about 100mg of Anhydrous Sodium Sulfate. Shake and filter. Divide the filtrate into equal part. One part is to add one ml of Concentrated Sulfuric Acid by allowing it to run down the inside of the test tube. Hold the test tube at a 45o angle. Note that immediate color changes is formed at the junction of the extract and Sulfuric Acid. Gently mix. Observer the color that immediately changes over a period of an hour. Use the other test tube as standard.

(+) result is the appearance of a red color indicated the presence of unsaturated sterol and /or triterpenes.

Kedde Reaction

To five ml of the 80% ethanolic extract in an evaporating dish. Add five ml of Kedde Reagent and mix well with a stirring rod. To the mixture, add about two ml of 1N Sodium Hydroxide. Mix and determine color development. 

(+) result: blue-violet to purple color is positive result indicating of the presence of the unsaturated lactone ring.

F. Test for Flavonoids

Evaporate to equivalent of ten grams of alcohol plant extract to incipient dryness over a water bath. Cool to room temperature. Triturate the residue with ten ml of pertoleum ether and decant. Repeat triturating of the residue with fresh volumes until the equivalent is almost colorless. Discard the petreoleum ether extract. Dissolve the defatted residue in twenty ml of 80 percent ethyl alcohol. Filter off any insoluble residue. Divide into 4 parts, labeling A,B,C and D. Keep test tube A as control.

Bate-Smith and Metcalf Test for Leucoanthocyanins 
 
Test tube B is to add half a ml of Concentrated HCl. Observe changes in color. Record the data. Warm the test tube on a water bath for fifteen minutes. Observe any color change within an hour, record results. Gradual development of a strong red or violet color is indicative of the precense of Leucoanthocyanins. Color formation may be dramatically slow. If the color is not immediately apparent, allow the test solution to stand at room temperature for about an hour before getting the result as negative.

Wilstatter “Cyanidin Test”

To test tube C, add a half ml of Concentrated HCl, and three or four pieces of magnesium ribbons. Take note of any color change (green, red ….) within ten minutes. Compare with test tube that serves as control. NOTE: Should definite appearance of coloration occur, cool. Dilute with an equal volume of water and add one ml of Octyl Alcohol. Shake and allow to separate. Note color in each layer.

(+) result is orange to red or crimson and magenta or greenish-blue color, which is reduction of magnesium metal

Test For Anthraquinone

Borntrager Test

Steam bath one gram of alcoholic plant extract to evaporate into dryness. Have a residue in ten ml of distilled water and filter. Discard the residue. Extract the filtrate with five ml of benzene extracts into two portions. Dividing the two combined benzene extracts into two equally portions. Reserve one as control. To the second portion add five ml of ammonia solution, then shake. Observe the alkaline layer for color changes.

(+) result is presence of red coloration.  because of sublimation yellow crystals of anthraquinones reacts with KOH. 

Modified Borntrager Test

Evaporate the equivalent of one gram plant extract to the incipient dryness using a water bath. The residue is taken up with ten ml of 0.5N KOH and a ml of diluted (5%) Hydrogen Peroxide and stir. Heat on a water bath for ten minutes. Cool and filter. Discard the residue. Add Glacial Acetic Acid dropwisely until acidic to litmus paper. Extract with five benzene, two times. Divide the combined benzene extracts into two portions. Reserve one portion as control. Two to five ml of ammonia solution is to be added on second portion until alkaline. Observer the alkaline layer for color changes.

(+) result is pink color, because of sublimation yellow crystals of anthraquinones reacts with KOH. 

Test For Cyanogenic Glycosides

Guignard Test

Place two to five grams of crushed plant sample in a test tube. Moisten with water and add a few drops of Chloroform to enhance enzyme activity. One ml of one percent emulsion solution may also be added to insure hydrolysis of the glycoside. For a firm stopper on the tube, use cork from which is suspended a piece of picrate paper. The paper strip must not be touched the inner sides of the test tube. Warm the tube at 35-40 C or keep it at room temperature for two to three hours. Observe any change in color of the paper. 

(+) result is the appearance of various shades of red within fifteen minutes is a measure of relative concertration of cyanogenic glycosides. If no color is observed after three hours, absence of glycoside is indicated.

Test for Tannins and Polyphonels

Take the etanolic extract equivalent to ten grams of plant material. Evaporated to incipient dryness over a water bath and cool. Add twenty ml of hot distilled water to the residue. Mix well with stirring rod and allow to cool at room temperature spontaneously. Add five drops of 10% Sodium Chloride solution to salt out undesirable constituents. Filter and divide the filtrate into four test tubes A,B,C and D. Reserve the contents of test tube A as standard.

Gelatin Test

To test tube B, add three drops of one percent Gelatin Solution. To test tube C, add three drops of gelatin-salt reagent. Observe any formation of a precipitate. 

(+) result: Jelly precipitate of the gelatin indicates the presence of tannins.

Ferric Chloride Test

To test tube D, add five drops of Ferric Chloride Solution. Observe any color change or formation of precipitate. 

(+) result: A blue-black color may indicate the presence of hydrolysable tannins, while brownish-gree color or greenish blue or greenish black may indicate condensed tannins, if the gelative is positive. Polyphenolic compounds give a negative test.

Test for Resin

Phloroglucino Test

Evaporated the one gram equivalent plant extract to incipient dryness using a water bath. Add few drops of phloroglucinol solution and hydrochloric acid to the residue and observe. 

(+) result is that appearance of a heavy bloody red color.

Test for Fixed Oils and Volatile Oils

Stain Test

Boil two grams of the plant sample in ten ml of petroleum ether. Take a piece of a white paper, put two drops of petroleum ether extract. Note any stain produced. 

(+) result is permanent oily stain or spot is observed.

Tuesday, October 30, 2012

Herbal Condiments to Traditional Medicines

We do love cooking. And cooking uses a lot of ingredients to prepare a cuisine that is mouth-watering and delicious to our taste. But not all of us know that a some ingredients in our food can treat a minor illnesses at home. Most herbal condiments we used have their unique action to help us cure and mitigate some home illnesses. Such as garlic, onions, ginger, rosemary and alike contain special properties. As below listed and discussed, what could be the possible action/s and active constituent/s that associated to each herb.

1. Ginger - known to produce a very strong, aromatic and spicy flavor, that can mass the unwanted taste of the meat and fish in food.Traditionally used to mitigate sore throat using a decoction of the rhizomes as tea or chewing a raw piece of rhizome. It contains gingerol, zingerone, and zingiberone that can be involved to its action. Such other uses are antiseptic, relieving rheumatism and gas pain. Antiseptic property can be done by preparing a tincture of dried rhizomes with 70% alcohol and apply on superficial cuts and wounds. For rheumatism, pounding a roasted rhizome that mix with oil can be applied locally. Gas pain or tympanism, in children and adults, can be taken the decoction of the rhizome as tea.

2. Garlic - The most useful condiment in sauteeing and preparing of food. Garlic is oxidized by heat to produced a sulfurous odor that gives a very delicious small to the cuisine. But garlic is not only to be used for preparation of food, but also has an important medicinal action. Expert found out that garlic contains allicin, that manifests many activity. It is been found out that taking garlic everyday can reduce blood cholesterol and blood pressure. When cloves are crushed and rubbed in affected areas, it can relieve arthritis and rheumatism.

3. Onion - One of the most used herbal condiment in cooking. It could make a person cry without doing something because of the enzymes, alliinases. Onion can be used to treat cough by infusion of bulb and leaves with sugar. Having ingesting it regularly can benefit the lowering of bad cholesterol. Also applying as poultice either the boiled or roasted bulbs may be used.

4. Paprika - A spicy condiment used to flavor cuisines. It contains capsaicin and capsaicinoids that give spicy flavor. Capsiacin contributes an anti-arthritis and anti-rheumatism by adding the paprika powder into oil and applying on the affected part. It could relieve dyspepsia, but no known scientific basis is done.

5. Rosemary - Can be used to relieve cough by inhaling steam of strong decoction of herb, and taking decoction of herb as needed for diuretic and gas pain use. For rheumatism, soaking the affected area to a decoction of herb can relieve pain.

6. Turmeric - A yellow like custard color powder, most often used in Persian, Thai and Indian in their cuisines such as curry. Its smell and flavor is distinctive. Turmeric had been studied that prolonged use of it can help to lessen the occurrence of cancer in the future. Also anti-arthritis property and other diseases can be cured.

7. Annatto  - Used mainly as food coloring in culinary arts. But some people used the bruised leaves and applied on forehead and temples. It contains bixin and ethereal oil.

8. Cacao - Powdered form of beans can be used as chocolate drinks. Cocoa powder contains tryptophan, that stimulates mood regulatory neurotransmitter, serotonin. Serotonin is linked to cause well-being and happiness of humans. Phenylethylamine which is a love chemical. The cacao oil or theobroma oil is exploited in pharmaceutical industry as good base for suppositories, because of its racemic property, and does not melt in a normal room temperature, but liquifies in body temperature. 

9. Citrus fruits - Made into juices, flavors and food. It is a good source of Vitamins, mainly Vitamin C, minerals, citric acid and volatile oils. They can be used as aromatic bath, bleaching agent by cutting fruit and apply directly on the darkened areas. Used to inhale by individuals who faints and nauseated. Eating of these fruits can help strengthen your immune system.

10. Oregano - Contains volatile oils and carvacrol. Oregano is used in coughs by expressing the leaves to produce juice, mix with sugar and drink. Bruised leaves are directly applied on the abdomen, temple and abdomen, to relieve tympanism and headache, respectively.

Pharmaceutical Quality Control Calculations A1

Problem A1

Theoretical weight of 10 tablets is 5.12 grams. Each tablet contains 375 mg of active ingredient. Using these data, determine the following:

1. The amount of active ingredient needed to prepare 60,000 tablets.
A) 307.20 grams
B) 11.718 grams
C) 22.50 kilograms
D) 307.20 kilograms
E)  30.72 kilograms

2. The amount of active ingredient needed to prepare 70 kilograms batch.
A) 136.719 grams
B) 186.70 grams
C) 43.50 grams
D) 51.27 kilograms
E) 5.127 kilograms

3. Determine the percentage amount of additive A per tablet if its actual amount is 35% of total additives.
A) 26.76%
B) 14.81%
C) 9.37%
D) 15.83%
E) 25.63%

4. If the tablet weight specification requires a limit of +/-10%, determine the upper and lower control limits of the tablets.
A) 460.80g - 463.20g
B) 337.50g - 412.50g
C) 460.80mg - 583.20mg
D) 337.50mg - 412.50mg
E) 4.608g - 5.632g

5) At what amount of the active ingredient is the product considered to be expired?
A) below 337.50mg
B) below 375.00 mg
C) below 356.25mg
D) below 365.50mg
E) below 568.89mg

Answers and solution will be given next time!

Monday, October 29, 2012

FDA Philippines Warned the Public Against Certain Korean Noodles

Yes, it is true that FDA Philippines has recently released a warning to the public that certain Korean noodles have been contaminated with a chemical benzopyrene, a chemical that can cause serious damage to the cells and tissues, specifically malignant and carcinogenic neoplasm to consumers who able to ingest it. Nine Korean noodle brands had found out to possess such carcinogenic chemical. A company that was involved in the issue has given statement that their production and products are safe. But FDA Philippines Deputy Director Nazarita Tacandong said, “avoid buying Korean noodles for the meanwhile, yet to patronize the local products as of the moment.” Please be advised to take note about this incident and informed the public about this.

Sunday, October 28, 2012

Contractubex vs. Dermatix

Scars are fibrous tissue that produce when a normal skin is damaged or injured. Scar is the result of natural healing process of the skin when it is wounded. The size of scar is depending on the severity of the damaged skin part. There are types of scar formation, hypertrophic, keloid and atrophic. Hypertrophic is the common scar which is overproduced collagen and raised above the surrounding skin. It is occurred about 4 to 8 week from the closure of the wound. Keloid scarring is a type of scar which is overexpressed of collagen in the body, and usually identified to persons whose genes have history of keloids. It a seriously scar that grows uncertainly into large, tumorous but benign mass. It is distinguishable from hypertrophic, because hypertrophic is lacking in growth, while keloid is overgrowth. Atrophic is a scar that is pitted and recess, due to the underlying support of fat or muscle is missing. This type of scar is caused by acne, chicken pox and staphylococcus infection in the skin.

Impact of scar to our daily life is so enormous. Scar can cause diffidence, low self-esteemed, shame and humiliation. Scar can be a problem to physical, emotional and psychological aspects of our lives. Having them can ruin your life, especially when skin is your asset and main source of income. People find a way to remove scar in their body. Such plastic surgery, consulting to dermatologists and other advanced technology are being consulted to eliminate it, but those procedure are very expensive enough to be compensated by normal people, so products that are easily acquired in the market, cost-effective and easily to administer and apply are the products looking by the consumer.

Their are two scar remover products in the market today, ContratubexTM and DermatixTM, are clinically proven and prescribed by medical doctors in removing scars. The two are recommended to patient who have been undergone a surgical procedure, cesarean delivery, major skin injuries, burns, and other scarring activity.

ContratubexTM can be procured in 100mg gel. Its ingredients are Extract Cepea 10g, Heparin 5000IU and allantoin. Extracy Cepea has shown bactericidal and anti-inflamatory action, and prevent the formation of scar tissue. Heparin is used in medicine as antifibrolytic. It helps to regenerate cell, soften the tissue, has anti-swelling properties and conserve water in the tissue for faster regeneration. Allantoin is known to be the activator of regeneration of the wound to heal, relieves itching and promotes penetration through the skin and softening it.

DermatrixTM is available in two dosage forms, gel and sheets. Its active ingredients are cyclic and polymeric siloxane and Vitamin C ester. Cyclic and polymeric siloxane (cyclopentasiloxane) has a powerful flattening and softening action in the tissue and Vitamin C to help protect from the ultraviolet rays of the sun causing pigmentation in the scar or darkening and promotes lightening to the skin.

The two products are used twice a day, can be used by children, and can be used with make-up.

But which of the two is most used and effective in removing scar?

Most prescription I received in the drugstore is ContractubexTM, maybe their promotion to doctors are very serious and active. Both may have same effect, but in promotional activities are not the same. They have been shown in the TV ads already. But in my personal opinion, ContractubexTM is more effective, because I can see that having three active ingredients is far more behind than the other. Having heparin and allantoin to promote regeneration is more important that to lighten the scarred skin. Regeneration is the main aim in using it. It has also an anti-inflammatory effect and bactericidal that support the regeneration of cell faster by not allowing to infect and itch, that can cause further scarring. Advantage of DermatixTM is that you can simultaneously use the gel with the sheet for faster effect.

Saturday, October 27, 2012

Glutathione: The Master Antioxidant

Skin whitening is very rampant today in the world of cosmetology and beautification. Because of this trend, people seemingly follow it and want their skin to be fairer and fairer until such whiteness has been achieved. Philippines is a country which has a tropic, mild and conducive weather to live on. The climate is cool to moderately hot compared to places in the north hemisphere and south hemisphere where cold weather is often felt in year around. Filipinos much be lucky of having brown skin where other races envy most.
They must be proud about it and much preserved it, because it is a gift from up above. But why some Filipinos want to be fair? Why are they aspired whitened skin while others are wanting their complexion?

As scientific research has been deepened, new technology in skin whitening is just on the tip of the finger. Advanced technology such as skin bleaching, whitening creams and lotions, vitamin c treatment, skin detoxification, and the introduction of glutathione (GSH), which is now a very famous, as the master of all antioxidants, and effective to whiten skin in just stint of time. What is Glutathione? And what is the main function in the body? Why it is used as oral or intravenous drug in whitening skin?

Glutathione (GSH)  is a tripeptide combination of three amino acids glutamyl-cysteine-glycine is used in many important biochemical reactions. Glutathione is an intracellular molecule for protection of cells and detoxification of reactive electrophilic compounds. It is found and mainly produced in the liver, so that no need to take oral glutathione or its IV counterpart.  Through the functional sulfhydryl group of the cysteine, GSH reacts chemically and enzymatically via the enzyme glutathione S-trasferase, with reactive oxidative oxygen groups of certain drugs, specifically aromatic hydrocarbons that formed during oxidative biotransformation. These reactive oxidative molecules may react with oxidative macromolecules such as proteins in the cell, leading to cell damage and cellular death. Thus, GSH is very important in the detoxification and biotransformation of reactive oxygen molecules into nonreactive metabolites. The resulting GSH conjugates are precursors for a group of drug conjugates known as mercapturic acid (N-acetylcysteine) derivatives.

Henceforth, Glutathione is involved mainly in the detoxification and biotransformation of oxidative chemicals that within our body, oxidative chemicals that cause mutation in the cell, particularly DNA and RNA. This deformation of DNA and RNA is the start of malignancy and cancer. The Glutathione is clearly used as antioxidant and not to whitening the skin. The whitening effect is maybe the side effect of Glutathione in higher dose when administered. The GSH's side effect may be associated with the impediment of melanogenesis, that is the formation of melanin from tyrosine which catalyze by tyrosinase to convert into dopa. Dopa is converted into dopaquinone which converted into leucodopachrome and converted to dopachrome. Dopachrome is converted to 5,6-dihydroxyindole-2-carboxylic acid to quinone until melanin is formed. It is believed that GSH inhibits the conversion of tyrosine into dopa by displacing the tyrosinase enzyme and interacts with it. Through this inhibition process, fairer skin is achieved.

There are no fatal adverse effect found in the use of Glutathione. But some experts say that it could lead to toxification of the liver or liver dysfuncton when higher dosage is given. Also the kidneys are commonly affected, especially in excretion of end metabolites of glutathione in the body. I believe that all excess are harmful to the body.


Friday, October 26, 2012

Cervical Cancer Vaccines

In the modern world today, teenagers are not safe from contracting infectious disease from premarital sex. Sexually Transmitted Infections (STIs) are very common to those who are sexually active and having multiple sexual partners. Protection when having sex is the most significant to do to avoid contracting diseases. Such use of condoms is the smartest thing to do to help each other from transferring them. But protection does not technically mean that you are safe from other diseases that cause severe diseases in the future. Cervical cancer is the one of the most helpless disease that can occur to people with active sexual lifestyle and multiple partners. This cancer caused by Human papillomavirus is contracted through the years the person is actively in sex. This HPV is been associated more in women because it is the cervix that usually affected and targeted.

Prevention of cervical cancer caused by Human papillomavirus can be prevented through introduction of some vaccines that can help to immunize the body to build-up antibodies to fight against the infectious disease. There are two leading prophylactic vaccines in the market today. Gardasil (Merck & Co.) and Cervarix (GSK). But which of the two is most useful and have significantly used to prevent the cervical cancer to women and possibly to men? 

Cervarix vaccine is a divalent vaccine having to prevent two types of HPV.  HVP types 16 and 18 are found to cause 70% of cervical cancer. They have been induced the cancers in the neck and head. It also contains a registered adjuvant ASO4, which been found to increase and boost the immunity in long expand of time. While, Gardasil vaccine is a quadrivalent vaccine to prevent four types of HVP. Because it is a quadrivalent  vaccine, it has broad spectrum on different types of cancer. The HVP types 6, 11, 16 and 18 are types of virus that causing cervical cancer and other cancerous diseases that preventable when Gardasil is given. Having the same types of HPV with Cervarix, it has been used to prevent 70% of inducing cervical cancer, but Gardasil having with additional HPV types is an advantage. The other HPV types 6 and 11 are most likely to cause 90% of genital warts are preventable when this vaccine is administered. Also Gardasil can be given prevent men to have cancerous diseases that likely to have with that of women. The two vaccines are given in three shots within the six months. Giving the second shot in the second month after the first, and the third shot on the fourth month after the second dose is administered.

Most Widely Used

The two have the same main use and action to prevent cancers caused by HPV. But the two have different significant advantages according to the clinical studies and postmarket research. Cervarix has an advantage in popularity reason because of the promotional strategies they did, especially on appearance in television ads. Most OB-Gyne doctors recommended and preferred Gardasil to be given to their patients, because of its broad-spectrum in preventing different types of HVP. They also recommend to men to be vaccinated to help them avoid having contracting warts or even cancer. Within the cost-effectiveness, Cervarix is mostly likely to be cheaper than Gardasil, having ranged from PhP1,500.00 to PhP2,000.00, hence, Gardasil is expensive.

Wednesday, October 24, 2012

Drug-Related Problems

Problems in drugs cannot be eliminated how much we are been expert to them, and how careful or accurate we are in handling and dispensing them. I know that err is inseparable to human beings, and we are likely to stumble to it. However, I am much sure that problems are not just blamed to humans alone, but also with the circumstances happened that are uncontrolled and out-flowed without seeking them. These letting us to learn and correct the mistakes that could be possibly repeated in the future.

Categories of Drug-Related Problems
  1. Medication Errors 
    Any preventable event that may lead to inappropriate medication use or cause harm to the patient while the medication is in the control of a health care professional, patient or consumer.

CATEGORY A
Circumstances or events that have the capacity to cause error.  Harm is defined as death, or temporary or permanent impairment of body functions/structure requiring intervention. Intervention may include monitoring the patient's condition, change in therapy, or active medical or surgical treatment.


CATEGORY B
An error occurred but the medication did not reach the patient


CATEGORY C
An error occurred that reaches the patient, but did not cause harm.
  • Medication reaches the patient and is administered
  • Medication reaches the patient but not administered

CATEGORY D
An error occurred that resulted in the need for increased patient monitoring, but no patient harm.


CATEGORY E
An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm.


CATEGORY F
An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm.


CATEGORY G
An error occurred that resulted in permanent patient harm.


CATEGORY H
An error occurred that resulted in a near-death event such as Anaphylaxis or Cardiac Arrest


CATEGORY I
An error occurred that resulted in patient death.


  1. Adverse Drug Event
    It is an injury from medical intervention related to a drug and includes ADRs, but also includes preventable reactions, including those caused by human error.
  • Patient Factors
    • Adverse Drug Reactions
    • Patient's Reaction to the drug
  • Drug Factors
    • Drug-Drug interactions
    • Drug-Food interactions
    • Drug-Disease interactions
    • Drug-Herbal interactions
    • and Other incompatibilities

CHANGE OF CIRCUMSTANCES

There are instances that changes occur in the pharmaceutical world. Sometimes they are not expected and anticipated to happen. All things are not permanent, though.There must be contingency plans to do, so that any change can manage right and the business shall not be affected and simultaneously operate without worries. I have listed below the most changes occur in the drugstore setting, with their associated requirements to comply, that unlikely to happen but they do. So, do not vex to face them, but have courage because in the end the business will surely succeed!

TRANSFER OF LOCATION OF DRUGSTORE
  • Letter request RE: Transfer of Location
  • Business Name Registration (DTI/SEC)
  • Contract of Lease/Proof of Ownership/Certification
  • Floor Plan with Dimension and Location Plan
  • Picture of Drugstore with Permanent Signboard
  • White Generic Label and Red Label
  • Rubber Stamp
  • Surrender Original LTO
  • Reissuance Fee P500.00


CHANGE OF BUSINESS NAME FOR DRUGSTORE
  • Letter request RE: Change of Business Name
  • Notarized Petition Form and Joint Affidavit of Undertaking
  • Business Name Registration (DTI/SEC)
  • Picture of Drugstore with Permanent Signboard
  • White Generic Label and Red Label
  • Rubber Stamp
  • Surrender Original LTO
  • Reissuance Fee P500.00


CHANGE OF OWNERSHIP OF THE DRUGSTORE
  • Letter request RE: Change of Ownership
  • Deed of Sale or Transfer of Rights
  • Surrender Original LTO
  • All the requirements as in opening
  • Opening Fee


CHANGE OF PHARMACIST

 INCOMING PHARMACIST
  • Notarized Notice of Change of Pharmacist
  • Two (2x2) Colored ID Picture
  • Board Certificate
  • Valid PRC ID
  • Current PTR
  • Duties and Responsibilities
  • Licensing Seminar (RD1)
  • Resignation Letter from previous employment signed by employer

 OUTGOING PHARMACIST
  • Resignation Letter signed by the employer

Tuesday, October 23, 2012

Total Parenteral Nutrition

TOTAL PARENTERAL NUTRITION (TPN) is an intravenous administration of calories, nitrogen and other nutrients in sufficient quantities to achieve tissue synthesis and anabolism. It is originally, the term hyperalimentation was used to describe the procedure. Dudrick developed the technique for administering fluids for Parenteral Nutrition by way of the subclavian vein into the superior vena cava where the solution is diluted rapidly by the large volume of blood available, thus, minimizing the hypertonicity of the solution. Parenteral Nutrition is indicated for patients who are unable to ingest food due to carcinoma or extensive burns and patients who refuse to eat, as in the case of depressed geriatrics or young patients suffering from anorexia nervosa and surgical patients who should not be fed orally. Normal caloric requirement for adults is 2500 calories per day.

Formulation of TPN:
  1. Protein which is main source of amino acids
  2. Carbohydrates that provides energy
  3. Lipid as a source of essential fatty acids
  4. Electrolytes is for the proper enzymatic and energy conserving or expending reactions within the body. Examples are sodium, potassium, magnesium, calcium, chloride, phosphates and alike.
  5. Traces of elements such as zinc, copper, selenium, chromium, iron, manganese, cobalt, molybdenum and others.
  6. Vitamins for long-term therapy
  7. Fluids (lastly to be mixed in the procedure)

Container
 Is made from silicone based bags that superseded by polyvinyl chloride and ethylvinyl acetate.

Storage Condition and Packaging
It is usually stored at a range from  2 to 6 degrees Celsius, but not allowed to be stored at room temperature for periods in excess of 12 to 24 hours required for administration. It is packaged in a polystyrene containers.

Counseling and Communication to Patient

Patient Counseling is a provision of oral or written information about drugs and other health-related information to a patient or his/her representative during the dispensing process or stay in the hospital.

Scope of Counseling
  • Generic Name and trade name of the drug
  • Techniques for self-monitoring
  • Use, action and onset of the drug
  • Potential drug interaction
  • Route, dosage form and storage condition
  • Contraindications
  • Directions for use
  • Relationship with laboratory tests or X-ray procedure
  • Action in case of missed dose
  • Disposal of drugs and devices
  • Precautions
  • Side effects and Adverse effects
  • Any other relevant health information unique to an individual patient

Communication Skills

Attending and Active Listening Skills 
  •  Stop talking
  • Get rid of distractions
  • React to the ideas, NOT to the person
  • Read non-verbal messages
  • Listen to how something is said
  • Provide feedback to clarify something
Interviewing Skills
  • Ask open questions
  • Ask closed question
  • Check if the patient has understood or requires more information
  • Avoid suggesting during data-gathering phase
  • Provide a balance of questions
  • Do not jump into conclusion 
  • Keep goals of the conversation in mind 
  • Avoid shifting from one topic to another until one is finished
  • Maintain objectivity

Emphatic Responding Skills
  • Reflecting is concentrating on the emotional meaning of what the patient condition or said
  • Paraphrasing is conveying the essence of what was said
  • Focusing is getting back to the topic of conversation

Influencing Skills
  • Give relevant advice
  • Make good suggestions
  • Share correct information
  • Summarize main points of information given
  • Emphasize key points with " This is important..."
  • Supplement spoken word with written  instruction
  • Give reasons for key advice
  • Check for accuracy of patient's understanding 
  • Give definite, concrete, explicit instruction

Monday, October 22, 2012

ADVERSE DRUG REACTION (ADR)

Adverse Drug Reaction (ADR) is a response to a drug that is noxious and unintended that occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function. It is a result of the intrinsic properties of the drug and cannot be prevented.



There are different types of it that used to identify them in the expand of treatment. They are, as follows:
  • Type A or Augmentation
  • Type B or Bizarre
  • Type C or Continuous
  • Type D or Delayed
  • Type E or End of use
  • Type F or Failure of efficacy

TYPE A (AUGMENTATION)
 It is a common, predictable and dose-related adverse drug reaction. And can be the dependent on clearance of the drug in the body that this drug reaction is incurred. There are two subtypes of it, either Extension Effects or Side Effects.
  1. Extension Effects can be related to pharmacological activity of the drug.
    Examples:
  • Tachycardia caused by salbutamol
  • Hypoglycemia caused by oral sulfonylureas
  • Sedation caused by CNS depressants
  • Hemorrhage caused by Anticoagulants
  1. Side Effects are not relevant to the pharmacological action of the drug.
    Examples:
  • Opiates that causing constipation
  • ACE inhibitors causing cough
  • Sedation by antihistamines
  • Headache by nitroglycerine

TYPE B (BIZARRE)
It is not common to drugs, unpredictable and non dose-related reaction. Does not have relevance to the pharmacological action of the drug in the body.
Subtypes are Idiosyncrasy and Hypersensitivity Reactions
  1. Idiosyncrasy is a reaction basically linked and determined through the genes of the individual.
    Examples:
  • Antipsychotic drugs having malignant hyperthermia effect.
  • Carbamazepine, Phenytoin and Sulfonamides causing Stevens-Johnson Syndrome
  1. Hypersensitivity Reactions are immune responses to environmental antigens and stimuli resulting into symptomatic reactions upon secondary exposure to the same antigen again. Antigen is more known to be allergen.
    Types of Hypersensitivity Reactions:
  • Type I (Immediate or Anaphylactic Immune Response)
      • Categorized as the most common allergic reaction because after an antigen (eg. pollen) binds onto Immunoglobulin E, which found in the surfaces of mast cells, can cause a severe reaction risky to the life of individual. Repetition of exposure to the same allergen, having cross linking of the cell-bound IgE, could cause degranulation that stimulates the release of histamines, leukotrienes and prostaglandins which are the main cause of the anaphylaxis (penicillin), inflammation, urticaria (hives), rushes , hay fever, asthma, dyspnea and etc.
  • Type II (Cytotoxic Reactions)
      • It is initiated by antibody, either Immunoglobulin G or Immunoglobulin M, directed against the antigens found on the cell membrane of a given target cell such as leukocytes and erythrocytes. It resulted to complement mediated lysis of the cell.
        Examples are: 1) Hemolytic anemia caused by Methyldopa, Aplastic Anemia when Chloramphenicol is given, and when blood transfusion procedure is made.
  • Type III (Immune Complex Hypersensitivity)
      • The tissue deposition of antigen-antibody complexes with complementary activation and tissue damage
        Examples are: 1) Arthus reaction stimulates through IM or SQ administration, 2) SLE caused by Hydralazine, Phenytoin, Isoniazid, and Procainamide; and 3) blood dyscrasias or serum sickness.
  • Type IV (Cell-Mediated or Delayed Reaction)
      • The T-lymphocytes are sensitized by an antigen releasing lymphokines after subsequent contact with the same antigen. Lymphokines induce inflammation and activate the production of macrophages.
        Examples: 1) Tuberculin Skin Test; and Contact dermatitis caused by poison ivy and nickel.


TYPE C (CONTINUOUS)
It is also uncommon but dose and time related reaction. Can be associated with the cumulative dose of the the drug that is taken or given.
Subtypes:
  1. Addiction is a condition where a person takes the drug compulsively, despite of potential harm that might cause to themselves, or their desire to stop. Examples are such addiction to marijuana or opiates.
  2. Dependence is a compulsion to take the drug repeatedly and experiences unpleasant symptoms if discontinued. Examples are benzodiazepines, caffeine in coffee and cocaine dependence.

    Classification of Dependence
  • Physical Dependence is an occurrence when a drug has been used habitually and the body has become accustomed to its effects. The person must then continue to use the drug in order to feel normal that when absence of it will trigger symptoms of withdrawal.
  • Psychological Dependence is occurred when a drug has been used habitually. The mind has become emotionally reliant to its effects, either to elicit pleasure or relieve pain, and does not feel capable of functioning without it.
  1. Tolerance is the deregulation of receptor site, which the drug reduced its effect with repeated use, thus, a higher doses of it must be introduced to produce the same effect. Examples are Nicotine and prednisone.
TYPE D (DELAYED)
The drug reaction is manifested when a drug is used for long term.

Subtypes:
  1. Carcinogenicity is the ability of any compound or substance to produce or induce tumor and cancer.
    Examples:
    Afltoxin
    Nitrosamines
    Aromatic Hydrocarbons
    Antineoplastic agents
    Heterocyclic amines
  2. Teratogenicity is the ability of a substance to cause congenital and malformations to fetus (birth defects) when the mother is exposed it.
    Examples:
    Carbamazepine and Valproic Acid that cause neural tube defects
    Diethylstilbestrol that can increase risk of developing vaginal adenocarcinoma after puberty
    Phenytoin causing fetal hydantoin syndrome
    Streptomycin damaging the 8th nerve ( sense of balance)
    Tetracyclines causing discoloration and defects of teeth and deformed bone growth
    Thalidomide causing phocomelia (penguin-like)
    Isotretinoin or Vitamin A powerful teratogen

TYPE E (END OF USE)
It is also uncommon. Most associated to withdrawal syndromes that generally occur shortly after stopping the drug.
Examples:
  • Opiates withdrawal
  • Rebound insomnia and excitation by Benzodiazepines
  • Rebound hypertension (Clonidine)
  • Rebound decongestant by Nasal decongestant
  • Addison's disease caused by steroids

TYPE F (FAILURE OF EFFICACY)
It is unexpected failure of efficacy. It is common and dose-related. May results from:
  • Drug-drug interactions
  • Use of counterfeit drugs
  • drug resistance
  • patient's non-compliance
  • wrong route of administration
  • drug instability

Saturday, October 20, 2012

Toxicology Detection of Poison

Hi there Students! I have here a table of Toxicology test that can help you to understand more your learning process in your toxicology class. I have provided in the table the tests, the poison detected and the positive results that will help to answer your laboratory experiment's questions. Hope it can help!

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