inactive ingredient guideline

IIG is a special part of FOI which includes list of inactive ingredient.

1. Inactive ingredient guideline By Saroj Makwana

2. Introduction IIG is a part of FOI Special Topics, which comes under Drug Information division of CDER. IIG was prepare on January 1996 PDF version available on FDA from March 2000 – scanned document B.K.MODY GOV.PHARMACY COLLAGE

3. Active ingredient Definition: (according to 21 CFR 210.3(b)(7 )) Include those components of the product that may undergo chemical change during the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. B.K.MODY GOV.PHARMACY COLLAGE

4. Inactive Ingredients Definition ( According to 21 CFR 210.3(b)(8 )) Only inactive ingredients in the final dosage forms of drug products are in the database of inactive ingredient guideline. B.K.MODY GOV.PHARMACY COLLAGE

5. Inactive Ingredients Inactive ingredients are components of a drug product that do not increase or affect the therapeutic action of the active ingredient, which is usually the active drug. Inactive ingredients are added during the manufacturing process of pharmaceutical products such as tablets, capsules, suppositories, and injections. B.K.MODY GOV.PHARMACY COLLAGE

6. Inactive ingredients may also be referred to as inert ingredients or excipients, and generally have no pharmacological effect. Examples: Binding materials D yes, P reservatives, F lavoring agents. B.K.MODY GOV.PHARMACY COLLAGE

7. Purpose Establishing the required quantities of the inactive ingredient for a particular dosage form with a specified route of administration is one another critical step involved in the design of a formulation. USFDA has provided information to some extent with relating to maximum potency of the inactive ingredient for a specific dosage form with specific route of administration. USFDA indicates that for new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product.

8. IIG Description NAME ROUTE /DOSAGE FORM CAS NUMBER UNII MAXIMUM POTENCY POTENCY RANGE B.K.MODY GOV.PHARMACY COLLAGE 1. INACTIVE INGREDIENT NAME:- Alphabetically listed Starting from ACACIA to ZINC SULFATE Then few excipients as per Numerical starting e.g . 1, 1, 1 – TRICHLOROETHANE

9. 2.ROUTE /DOSAGE FORM DOSAGE FORM : Tablet: Delayed action, Enteric Coated Emulsion Suspension ROUTE : Buccal I.M. I.V. Ophthalmic Oral Topical

10. 3.CAS No . Chemical Abstract Service No. 9 digit Provides comprehensive electronic chemical information services . Helpful in Computer-assisted search with the National Library of Medicine’s Online Databases for chemical information B.K.MODY GOV.PHARMACY COLLAGE

11. 4. UNII Unique Ingredient Identifier Part of the joint United States Pharmacopeia (USP)/FDA Substance Registration System (SRS) Provide unique identifiers for substances in drugs, biologics, foods, and devices based on molecular structure and/or descriptive information . The SRS is used to generate permanent, unique, identifiers for substances in regulated products, such as ingredients in drug products. B.K.MODY GOV.PHARMACY COLLAGE

12. 5. Maximum potency The "maximum potency" field specifies the maximum amount of inactive ingredient for each route/dosage form containing that ingredient. When there is no calculable potency measurement for the inactive ingredient, the "maximum potency" field will be blank. B.K.MODY GOV.PHARMACY COLLAGE

13. 6. POTENCY RANGE Minimum to Maximum Value of Excipients used i.e . 0.5 mg – 5 mg In many excipient Potency Range is given in Percentage of final product i.e. 0.5 % - 5 % B.K.MODY GOV.PHARMACY COLLAGE

14. Study Questions Write a note on IIG. (June/July- 2011, July 2010,2012) What is objective of IIG? Explain general description of IIG.(Dec. – 2011, Winter- 2012) B.K.MODY GOV.PHARMACY COLLAGE

15. REFERENCES: www.fda.gov www.fda.gov/cder/drug/iig/default.htm B.K.MODY GOV.PHARMACY COLLAGE

16. THANK YOU