際際滷

際際滷Share a Scribd company logo

Guidance on tablet scoring

Download as PPTX, PDF
N
Naga Ajay Kumar Dintakurthi

Through this Guidance you are able to understand the basics requirements of Table scoring, agencies recommendations and data to be generated on split tablets.

1 of 13
Downloaded 64 times
TABLET SCORING: NOMENCLATURE, LABELING, AND DATA FOR EVALUATION A scoring feature facilitates the practice of tablet splitting
CONTENTS Introduction Background Discussion Guidelines and Criteria Nomenclature and Product labeling
INTRODUCTION This document provides guidance for NDAs and ANDAs having tablets that have been scored. It provides: Guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet. Nomenclature and labeling for approved scored tablets This guidance does not address specific finished product release testing, where additional requirements may apply to scored tablets.
BACKGROUND What? Score - a debossed line running across the planar surface of the tablet. Why? It facilitates the breaking of tablet into fractions when less than a full tablets is required for a dose. (In the same manner as the listed drug) RLDVS Generic If RLD is scored, then Generic should be scored. If RLD is not scored, then Generic should not be scored. If scoring configuration is patented, then it should be discussed with OGD.
BACKGROUND Scoring of tablets facilitates the splitting of tablet into fractions when less than a full tablet is desired for a dose. (For adjusting the dose in the same manner as the RLD) Although there are no standards or regulatory requirements that specifically address scoring of tablets, Agency recognizes the need for consistency scoring between a generic product and its RLD. Agency concluded that tablet splitting have safety issues in some cases. Concerns with splitting of tablet include variations in the tablet content, weight, dissolution or disintegration. In addition, there may be stability issues with splitting tablets. How much drug is present in split tablet and available for absorption
DISCUSSION As an outgrowth of these discussion,Agency is providing recommendations for applicant content regarding the scientific basis for functional scoring on solid oral dosage form products to ensure the quality of both NDA andANDA scored tablet products. Guidelines and Criteria Nomenclature and Product labeling
GUIDELINES AND CRITERIA Split tablet dose should not be below the minimum therapeutic dose indicated on the approved labeling. Safe to handle and should not pose unintended drug exposure. Modified release products for which the control of drug release can be compromised by tablet splitting should not have a scoring feature. The split tablet, when stored in pharmacy dispensing containers (no seal/no desiccant), should demonstrate adequate stability for a period of 90 days at 25賊2尊 C, /60賊5 RH Meet all finished products specifications (Mechanical and Non mechanical) Scoring configuration of generic drug products should be the same as the RLD. An evaluation of tablet splitability should be done during post approval changes at Level -2 and Level -3. Below are the guidelines and criteria by which a scored tablet characteristics are evaluated as part of review process are
CRITERIA For Immediate Release SolidOral Dosage Forms: Uniformity of Dosage Unit - USP General Chapter <905> Here one split portion of a whole tablet is considered as a unit dose and should meet the uniformity of dosage unit requirements. Testing forWeight Variation: It is allowed for split tablet portion intended to have 25mg or more of a drug substance that comprises 25 percent or more (by weight) of the split portion. Otherwise, the test of Content Uniformity should be used. Tablet Splitability (Mechanical and Non-mechanical) The tablets splitability to be tested at both ends of proposed hardness range. 1. Loss of mass: 15 tablets to be tested to ensure the loss of mass less than 3.0% between the individual segments when compared to the whole tablet. 2.Split tablets portions should meet USP Friability requirements. Dissolution Dissolution data on split tablet portions should meet finished product release requirements.
CRITERIA Parameter Modified Release Solid Oral Dosage Forms (Using MatrixTechnology) Modified Release Solid Oral Dosage Forms (Using Compressed Film Coated Components) UOD,Tablet splitability. All criteria mentioned for Immediate release dosage should be met. All criteria mentioned for Immediate release dosage should be met. Dissolution a) Dissolution should be demonstrated at both ends of the hardness range. b) Dissolution on whole versus split tablet portions should meet the similarity factor (f2) criteria. (a+b) and c) Dissolution profile on pre-compressed beads versus post-compressed whole and split tablet portions should meet similarity factor (f2) criteria to ascertain the integrity of beads during compression. For Modified Release Solid Oral Dosage Forms:
NOMENCLATURE AND PRODUCT LABELING The New products meeting the above criteria can be labeled as functional scoring. And it should be appear in Dosage form and strength, How supplied sections of label. For current marketed products, manufactures have the option to perform an assessment and provide data for evaluation.
REFERENCES FDA Guidance for IndustryTablet Scoring: Nomenclature, Labeling, and Data for Evaluation March 2013 MAPP on scoring configuration of Generic drug products (5223.2), November 1, 1995.
Guidance on tablet scoring
THANKYOU

More Related Content

Guidance on tablet scoring

  • 1. TABLET SCORING: NOMENCLATURE, LABELING, AND DATA FOR EVALUATION A scoring feature facilitates the practice of tablet splitting
  • 2. CONTENTS Introduction Background Discussion Guidelines and Criteria Nomenclature and Product labeling
  • 3. INTRODUCTION This document provides guidance for NDAs and ANDAs having tablets that have been scored. It provides: Guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet. Nomenclature and labeling for approved scored tablets This guidance does not address specific finished product release testing, where additional requirements may apply to scored tablets.
  • 4. BACKGROUND What? Score - a debossed line running across the planar surface of the tablet. Why? It facilitates the breaking of tablet into fractions when less than a full tablets is required for a dose. (In the same manner as the listed drug) RLDVS Generic If RLD is scored, then Generic should be scored. If RLD is not scored, then Generic should not be scored. If scoring configuration is patented, then it should be discussed with OGD.
  • 5. BACKGROUND Scoring of tablets facilitates the splitting of tablet into fractions when less than a full tablet is desired for a dose. (For adjusting the dose in the same manner as the RLD) Although there are no standards or regulatory requirements that specifically address scoring of tablets, Agency recognizes the need for consistency scoring between a generic product and its RLD. Agency concluded that tablet splitting have safety issues in some cases. Concerns with splitting of tablet include variations in the tablet content, weight, dissolution or disintegration. In addition, there may be stability issues with splitting tablets. How much drug is present in split tablet and available for absorption
  • 6. DISCUSSION As an outgrowth of these discussion,Agency is providing recommendations for applicant content regarding the scientific basis for functional scoring on solid oral dosage form products to ensure the quality of both NDA andANDA scored tablet products. Guidelines and Criteria Nomenclature and Product labeling
  • 7. GUIDELINES AND CRITERIA Split tablet dose should not be below the minimum therapeutic dose indicated on the approved labeling. Safe to handle and should not pose unintended drug exposure. Modified release products for which the control of drug release can be compromised by tablet splitting should not have a scoring feature. The split tablet, when stored in pharmacy dispensing containers (no seal/no desiccant), should demonstrate adequate stability for a period of 90 days at 25賊2尊 C, /60賊5 RH Meet all finished products specifications (Mechanical and Non mechanical) Scoring configuration of generic drug products should be the same as the RLD. An evaluation of tablet splitability should be done during post approval changes at Level -2 and Level -3. Below are the guidelines and criteria by which a scored tablet characteristics are evaluated as part of review process are
  • 8. CRITERIA For Immediate Release SolidOral Dosage Forms: Uniformity of Dosage Unit - USP General Chapter <905> Here one split portion of a whole tablet is considered as a unit dose and should meet the uniformity of dosage unit requirements. Testing forWeight Variation: It is allowed for split tablet portion intended to have 25mg or more of a drug substance that comprises 25 percent or more (by weight) of the split portion. Otherwise, the test of Content Uniformity should be used. Tablet Splitability (Mechanical and Non-mechanical) The tablets splitability to be tested at both ends of proposed hardness range. 1. Loss of mass: 15 tablets to be tested to ensure the loss of mass less than 3.0% between the individual segments when compared to the whole tablet. 2.Split tablets portions should meet USP Friability requirements. Dissolution Dissolution data on split tablet portions should meet finished product release requirements.
  • 9. CRITERIA Parameter Modified Release Solid Oral Dosage Forms (Using MatrixTechnology) Modified Release Solid Oral Dosage Forms (Using Compressed Film Coated Components) UOD,Tablet splitability. All criteria mentioned for Immediate release dosage should be met. All criteria mentioned for Immediate release dosage should be met. Dissolution a) Dissolution should be demonstrated at both ends of the hardness range. b) Dissolution on whole versus split tablet portions should meet the similarity factor (f2) criteria. (a+b) and c) Dissolution profile on pre-compressed beads versus post-compressed whole and split tablet portions should meet similarity factor (f2) criteria to ascertain the integrity of beads during compression. For Modified Release Solid Oral Dosage Forms:
  • 10. NOMENCLATURE AND PRODUCT LABELING The New products meeting the above criteria can be labeled as functional scoring. And it should be appear in Dosage form and strength, How supplied sections of label. For current marketed products, manufactures have the option to perform an assessment and provide data for evaluation.
  • 11. REFERENCES FDA Guidance for IndustryTablet Scoring: Nomenclature, Labeling, and Data for Evaluation March 2013 MAPP on scoring configuration of Generic drug products (5223.2), November 1, 1995.