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Quality Attribute Considerations for Chewable Tablets Guidance for Industry - PharmaFacts
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Quality Attribute Considerations for Chewable Tablets Guidance for Industry

Quality Attribute

Considerations for

Chewable Tablets Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact (CDER) Nallaperumal Chidambaram 301- 796-1339.

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

June 2016 Pharmaceutical Quality/CMC

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17051dft.doc

Quality Attribute

Considerations for

Chewable Tablets Guidance for Industry

Additional copies are available from:
Office of Communications, Division of Drug Information Center for Drug Evaluation and Research

Food and Drug Administration th 10001 New Hampshire Ave., Hillandale Bldg., 4

Floor

Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

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U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

June 2016 Pharmaceutical Quality/CMC

 

I. II. III.

A. B. C. D. E.

IV. A.

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 DISCUSSION .................................................................................................................... 2 Hardness ......................................................................................................................................... 3 Disintegration ................................................................................................................................. 3 Dissolution ...................................................................................................................................... 3 Performance in Simulated Physiological Media ......................................................................... 4 Biowaiver and Postapproval Considerations .............................................................................. 4 RECOMMENDATIONS.................................................................................................. 4 Critical Quality Attributes ............................................................................................................ 5 Nomenclature and Labeling .......................................................................................................... 7

Contains Nonbinding Recommendations

Draft — Not for Implementation

TABLE OF CONTENTS

B.
APPENDIX I: CHEWING DIFFICULTY INDEX.................................................................. 8 FIGURES....................................................................................................................................... 9 APPENDIX II: SIMULATED SALIVARY FLUID COMPOSITION .................................10

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