FDA发布咀嚼片关键质量属性指导原则

I. INTRODUCTION
This guidance provides manufacturers of chewable tablets2 for human use with the Center for Drug Evaluation and Research’s (CDER) current thinking on the critical quality attributes that should be assessed during the development of these drug products.3 This guidance also provides recommendations for sponsors/applicants regarding the submission of developmental, manufacturing, and labeling information for chewable tablets in applications. The recommendations in this guidance apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs),4 and certain chemistry, manufacturing, and controls (CMC) supplements to these applications.5 Some of the recommendations about the submission of developmental information may also apply to investigational new drug applications (INDs). The recommendations about assessing critical quality attributes apply to all immediate release (IR) chewable tablets for human use, including non-application products.
Pharmaceutical Quality/CMC
8938436 FNL
Quality Attribute Consideratiouidance for Industry
Additional copies are available from: Office of Communications, Division of Drug Information
Quality Attribute Considerations for Chewable Tablets
Guidance for Industry
U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) August 2018
Contains Nonbinding Recommendations
Quality Attribute Considerations for Chewable Tablets Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.
Center for Drug Evaluation and Research Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002
TABLETS ........................................................................................................................ 10 FIGURES..................................................................................................................................... 12 APPENDIX II: SIMULATED SALIVARY FLUID COMPOSITION ................................ 13
A. Hardness ......................................................................................................................................... 3 B. Disintegration ................................................................................................................................. 3 C. Dissolution ...................................................................................................................................... 4 D. Performance in Simulated Physiological Media ......................................................................... 4 E. Use of In Vitro Bioequivalence Data and Postapproval Considerations .................................. 5 IV. RECOMMENDATIONS.................................................................................................. 5 A. Patient Acceptability and In vivo Performance .......................................................................... 5 B. Buccal Absorption.......................................................................................................................... 6 C. Critical Quality Attributes ............................................................................................................ 6 D. Nomenclature and Labeling.......................................................................................................... 8 APPENDIX I: CHEWING DIFFICULTY INDEX FOR FLAT-FACED ROUND
Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 2 III. DISCUSSION .................................................................................................................... 2
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