IPP REVENUE HITS

Thursday, March 26, 2015

Insulin



Insulin Injection, USP, BP, PhI.

Other Name: Injectio Insulin; Insulin; Insulin Hydrochloride; Iletin (Lilly).

Definition: A sterile, acidified solution of the active principles of the pancreas which affects the metabolism of glucose.

Description: Colorless or almost colorless liquid when containing in each milliliter not more than 100 USP Units. When contain 500 USP Units it may be straw – colored. It is substantially free from turbidity and from insoluble matter. When determined through potentiometrically, the pH of the injection is between 2.5 and 3.5.

Uses: The specific therapeutic use of insulin is in the treatment of diabetes mellitus. Also it is used in the treatment of underweight individuals, the purpose being to stimulate the appetite by lowering the level of blood sugar.

Dose: 5 to 100 USP Units; usual, subcutaneous, according to the needs of the patient.



Isophane Insulin Suspension, USP, BP

Other Names: Isophane Insulin; Isophane Insulin Injection; NPH Insulin; NPH Iletin (Lilly).

Definition: Isophane Insulin Suspension is a sterile suspension, in a buffered water medium, of insulin made from zinc – insulin crystals modified by the addition of protamine in a manner such that the solid phase of the suspension consists of crystals composed of insulin, protamine and zinc. Protamine is prepared from sperm or from the mature testes of fish belonging to the genus Oncorhychus Suckley, or Salmo Linne (Family Salmonidae) and conforms to the regulations of the Federal Food and Drug and Administration concerning certification of drugs composed wholly or partly of insulin.

To prepare Isophane Insulin Suspension, sufficient insulin is used to provide either 40 to 80 USP Units for each milliliter of suspension.

Description: White suspension of rod – shaped crystals approximately 30 microns in length and free from large aggregates of crystals following moderate agitation.

Use: Intermediate – acting insulin preparation used for the treatment of diabetes mellitus. Action of this suspension begins in 1 to 2 hours, reaches a peak in 10 – 20 hours and lasts 28 – 30 hours.


Protamine Zinc Insulin Suspension, USP, BP, PhI.

Other Names: Injectio Zinco Insulinae Protaminati; Protamine Zinc Insulin; Protamine Zinc Insulin Injection; Protamine Zince and Iletin (Lilly).

Definition: it is a sterile suspension, in a buffered water medium, of insulin modified by the addition of zinc chloride and protamine. The protamine is the same as that used in Isophane Insulin and it follows the same regulations of the Federal Food and Drug Administration. Insulin used is the same amount as that of Isophane Insulin.

Uses: Due to the slower onset of action (4 to 6 hours) this insulin need not be given with any definite time relation to food intake, and it must not be depended upon when very prompt action is needed, as in diabetes acidosis and coma. Also, because of the prolonged action (24 to 36 hours) the protamine zinc insulin need not be given more than one daily, but this should be done at a fairly uniform, scheduled time. The dose should be adjusted continues to demonstrate activity for 3 to 4 days.

Protamine zinc insulin and the more rapidly acting insulin have been mixed in various proportions and in different ways. Such variation produces mixtures that give intermediate patterns of speed and duration of physiological activity. This method, however, makes it possible through  the long acting insulin to take care of the sugar requirements during the night, while the short – acting insulin cause full utilization of food taken during the day.


Insulin Zinc Suspension, USP, BP, PhI.

Synonyms: Lente Insulin; Lente Iletin (Lilly): Clinica

Definition: A sterile suspension in a buffered water medium, of insulin modified by the addition of zinc chloride in such that the solid phase of the suspension consists of a mixture of crystals and amorphous insulin in a ration of approximately 7 parts of crystals to 3 parts of amorphous material.

Sufficient insulin is used to provide either 40 or 80 USP Insulin Units for each milliliter of the suspension.

Uses: Due to the slowness with which the large crystals dissolve the crystalline zinc insulin has a duration of action longer than 36 hours, while the “amorphous” has a duration of 12 to 16 hours. An appropriate dose of the 3:7 mixture used in Insulin Zinc Suspension has an immediate duration of action which is very close to that of Isophane Insulin Suspension (28 to 30 hours) with which it may be used interchangeably. Zinc Insulin Suspension has an advantage of its freedom from foreign proteins such as globin or protamine to which certain patients are sensitive.

Dose: Subcutaneous, 10 to 80 USP Units; usual, according to the needs of the patient.


Extended Insulin Zinc Suspension, USP

Other Name: Ultra – Lente Iletin (Lilly).

Definition: A sterile suspension, in a buffered water medium, of insulin modified by the addition of zinc chloride in a manner such that the solid phase of suspension is crystalline.

Sufficient insulin is used to provide either 40 or 80 USP Units for each milliliter of the suspension.

Uses: The crystals of the suspension are of sufficient size to have a slow rate of dissolution. For the same reason the duration of action is usually in excess of 36 hours which is slightly longer than that of Protamine Zinc Insulin. Because Extended Insulin Zinc Suspension is free of Protamine and other foreign proteins, the incidence of allergic reactions is minimized.

The dose should be individualized to the patient on the basis of a study of response of blood and urine glucose to trial doses of the drug. The suspension is given by deep subcutaneous injection.

Dose: Subcutaneous, 10 to 80 USP Units; usual, according to the needs of the patient.


Prompt Insulin Zinc Suspension, USP

Other Name: Semi – Lente Iletin (Lilly).

Definition: Prompt Insulin Zinc Suspension is a sterile suspension, in a buffered water medium, of insulin modified by the addition of zinc chloride in a manner such that the solid phase of the suspension is amorphous.

Sufficient insulin is used to provide either 40 or 80 USP Units of Insulin for each milliliter of the suspension.

Uses: Zinc Insulin in this suspension is mixture of amorphous and extremely fine crystalline materials, thus the rate of dissolution is nearly maximal for the substance. But still the rate is slow enough that the suspension has a duration of action (12 to 16 hours) comparable to that the Globin Zinc Insulin. The incidence of allergic reactions is essentially free of foreign proteins.

Like the Insulin Zinc Suspension and Extended Insulin Zinc Insulin Suspension, the dose needs to be individualized to the patient on the basis of study of responses of the blood and urine glucose to trial doses of the drug.

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