USP〈1094〉 CAPSULES—DISSOLUTION TESTING AND RELATED QUALITY ATTRIBUTES

BRIEFING

〈1094〉 Capsules—Dissolution Testing And Related Quality Attributes. This proposal is based on the version of the chapter official as of December 1, 2020. Based on comments received, the following revisions are being proposed:

Include cross-reference to Oral Dosage Forms—Performance Tests 〈1711〉 in 1. Introduction.

Include some examples in 1.1 Types of Capsules of how capsules can be used in the administration of different formulations, and explain the differences in the manufacturing processes of softgels and hardgels; include pullulan capsules.

Add some means of providing evidence of cross-linking under 2. Cross-Linking in Gelatin Capsules.

Revise the use of rupture test and add cross-reference to Solubility Measurements 〈1236〉 in 3. Dissolution Procedure Development.

Include the reference to the FDA guidance on dissolution testing of immediate-release solid oral dosage forms containing highly soluble drug substances under 3.2 Medium.

Add information and recommendations in 3.2.3 Use of Enzymes regarding enzyme activity, specifically how to conduct dissolution testing in the presence of cross-linking in gelatin capsules and when the dissolution medium contains compounds that may denature the enzymes, and how to force cross-linking in gelatin capsules.

Add recommendations on the validation of Tier 2 step under 4. Method Validation.

Add the new sections: 4.1 Cleaning Considerations, 5.6 In vitro in vivo Correlations, 6.3 Brittleness, and 6.4 Overall Potential Capsule Defect Assessment.

Source from USP and Please refer to USP for details:

https://online.uspnf.com/uspnf/document/2_GUID-794D7F65-D715-4719-9A14-5C80B55C5FC9_10101_en-US?

hdpe bottles for pharmaceuticals

desiccant bottle with silica gel