INTRODUCTION
Topically applied drug products fall into two general categories: those applied to achieve local action and those applied to achieve systemic effects after absorption through the skin into the blood circulation. Local action can occur at or on the surface of the application site (e.g., stratum corneum); in the underlying tissues (e.g., epidermis and/or dermis); and in subcutaneous tissues (e.g., muscle or joint). Topically applied drug products include, but are not limited to, creams, gels, ointments, pastes, suspensions, lotions, foams, sprays, aerosols, solutions, and ▲topical and▲ (USP 1-Aug-2023)transdermal delivery systems (TDS). The definitions and descriptions of these dosage forms, as well as brief information on their composition and/or manufacturing processes, can be found in Pharmaceutical Dosage Forms 〈1151〉.
Procedures and acceptable criteria for testing topically applied drug products can be divided into those that assess general product quality attributes and those that assess product performance. The product quality attributes include the following: description, identification, assay (strength), impurities, physicochemical properties, uniformity of dosage units, water content, pH, apparent viscosity, microbial limits, antimicrobial preservative content, antioxidant content, sterility (if applicable), ▲penetration enhancer content,▲ (USP 1-Aug-2023)and other tests that may be product specific. Product performance testing assesses drug release and other attributes that affect drug release from the finished dosage form.
This chapter provides lists of consolidated common product quality test requirements in a concise and coherent fashion. This chapter applies, in whole or in part, when referenced in a drug product monograph (see General Notices, 3.10 Applicability of Standards) and includes the quality tests for the specific route of administration. The quality tests listed can be used as appropriate by manufacturers toward the development of new drug product monographs for submission to USP–NF.
TDS release their active ingredients by different mechanisms. They can be passive or active. This chapter covers only the tests related to passive TDS.
Change to read:
PRODUCT QUALITY TESTS FOR TOPICAL AND TRANSDERMAL DRUG PRODUCTS
Additional Procedure for Products Packaged in Containers with a Non-Metered Pump
For some tests (e.g., viscosity, assay, etc.), with the exception of the uniformity in containers test, samples need to be collected from the pumped-out product. In these instances, the samples should be collected as follows:
Remove cap from container.
Fully depress and release the actuator, disposing of any material dispensed, and allowing the pump actuator to return to the initial position after each actuation. Repeat the sequence, as indicated in the patient instructions, until a full amount of material is dispensed.
Collect the next material dispensed as the sample. Generally, collect NMT the amount needed to perform a single analysis (for the assay test, typically NMT 2 actuations).
Universal Tests
Universal tests [see International Council for Harmonisation (ICH) guidance Q6A—Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, available at www.ich.org] are listed as follows and are applicable to all topically applied drug products.
description
A qualitative description of the drug product should be provided. The acceptance criteria should include the final acceptable appearance of the finished dosage form and packaging. A visual examination should identify changes in color, adhesive migration (i.e., cold flow; see Cold Flow Test) for TDS, separations, crystallization, and others that are specific to the drug product. The description should specify the content or the label claim of the article. For TDS, a visual examination should also be done to assess potential use issues with the product. The examination should include an assessment of the difficulty of removing the TDS from the pouch (e.g., due to adhesive migration adhering the system to the pouch); inability to remove the TDS from the pouch without damage to the system; and adhesive residue remaining on the pouch after removal of the TDS. This is not a compendial test but is part of the manufacturer’s specification for the drug product.
Source from USP and Please refer to USP for details:https://online.uspnf.com/uspnf/document/2_GUID-B8C993EA-A7A3-4637-99C7-D887C4719895_501010201_en-US?source=TOC
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