Guidance on Formulating Semisolid Drugs size than expected and thereby raised questions about the product efﬁcacy. In addition to ingredient solubility and particle size, other physical characteristics and speciﬁcations for both ingredients and ﬁnished products are important.
The subjects covered here are generally applicable to all forms of topical drug products, including those that are intended to be sterile. The topics given below address several problem areas that may be encountered in the production of semisolid drug products (including transdermal products) including their potency, active ingredient uniformity, physical characteristics, microbial purity, and chemical purity.
EQUIPMENT AND PRODUCTION CONTROL
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When validating a suspension manufacturing process, determine how to ensure that the product remains homogeneous during the ﬁlling process and establish the data that support the adequacy of the ﬁrm’s process. When the batch size is large and the bulk suspension is in large tanks, determine how the low levels of bulk suspension near the end of the ﬁlling process are handled. If the bulk suspension drops
© 2004 by CRC Press LLC
Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products
below a level, can this be adequately mixed? This question must be answered. If the residual material transferred to a smaller tank, how is the reliance made on handmixing of the residual material? The adequacy of the process for dealing with residual material should be demonstrated.
It is therefore important that the following considerations be adequately addressed in a cleaning validation protocol and in the procedures that are established for production batches.
A. DETAILED CLEANING PROCEDURES C. PROCESS TEMPERATURE CONTROL
Typically, heat is applied in the manufacture of topical products to facilitate mixing or ﬁlling operations. Heat may also be generated by the action of high-energy mixers. It is important to control the temperature within speciﬁed parameters, not only to facilitate those operations but also to ensure that product stability is not adversely