This chapter provides general information about developing in vitro performance tests to evaluate drug release or skin permeation for topical and transdermal semisolid and liquid-based dosage forms, including but not limited to, creams, gels, ointments, pastes, suspensions, lotions, and foams. For information related to in vitro performance tests that evaluate drug release for transdermal delivery systems (TDS), refer to Drug Release 〈724〉.
In this chapter, the term “drug” is utilized to refer more generally to active ingredients, potentially including active ingredients that may not be considered drugs (e.g., sunscreen active ingredients).
For information related to product quality tests for topical and transdermal dosage forms, refer to Topical and Transdermal Drug Products—Product Quality Tests 〈3〉.
INTRODUCTION
This chapter provides general information for developing in vitro release test (IVRT) methods to assess the rate of drug release from topical and transdermal semisolid and liquid-based dosage forms, including but not limited to, creams, gels, ointments, pastes, suspensions, lotions, and foams applied on the skin and other mucosal membranes. Definitions and descriptions of these dosage forms can be found in Pharmaceutical Dosage Forms 〈1151〉. This chapter also provides general information for developing in vitro permeation tests (IVPT) to assess the rate and extent of drug permeation into and through the skin from semisolid and liquid-based drug products. The same equipment and similar methodological principles/procedures may be relevant for IVPT methods with other epithelial membranes (for information on appropriate mucosal membranes, see Biological Membrane below).
Drug Product Quality and Performance Tests
Drug product tests are divided into two categories: 1) those that assess general quality attributes i.e., product quality tests, and 2) those that assess product performance, e.g., using an IVRT/IVPT method. Product quality tests characterize the physicochemical and/or structural attributes (e.g., pH, particle size/morphology etc.) of the formulation. By contrast, product performance tests assess how a drug product functions under specified conditions, which may provide information relevant to its in vivo performance.
Product quality tests are generally useful to characterize and/or compare product quality attributes that can control the performance of the product, including, but not limited to, identity, strength, purity, uniformity, pH, particle size/morphology, and apparent viscosity. Details about these product quality tests can be found in 〈3〉. The performance tests that are the focus of this general chapter are specifically useful to characterize and/or compare the steady state drug release rate (using an IVRT) or the dynamic rate and extent to which a drug permeates into and through the skin (using an IVPT) from semisolid and/or liquid-based dosage forms, under the conditions of the test.
Potential contexts for use of IVRT and IVPT methods are summarized below.
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