Producing quality semi-solids literally boils down to five key physical characteristics: homogeneity, particle distribution, spreadability, grittiness and use of surfactants. If one element fails, then the entire process breaks down. Each element must be closely monitored from beginning to end and after sale to assure patients receive the correct medication in the specified concentration throughout the life of the product.
Pharmaceutical manufacturing of quality semi-solid products involves specialized homogenization requirements. Homogeneity is the state of being all of one kind. For manufacturing semi-solids, homogenization, or micronization, refers to the proportionate distribution of ingredients. The process utilizes various techniques to reduce particle sizes of pharmaceutical products using to increase stability and effectiveness.
Unlike liquid medications, proper homogeneity must exist within the large vessels used in the manufacturing process as well as within each individual tube and jar of product marked for commercial sale.
The distribution of API and other ingredients must be uniform in all container closure systems. For example, the same proportional distribution of medication must exist in a 2,000-gallon tank and also within a 1.75-ounce tube.
A faulty homogenization process may result in significant deficiencies in semi-solid quality. Poor homogenization may create lumpiness or globules due to insufficient or incomplete mixing of oil and water phases. This reduces the patient experience with the product and can create significant challenges during product application. Finally, irregular amounts of the API will be distributed on affected areas producing less than optimal effectiveness.
Correct results for quality homogenization demand a high level of equipment sophistication and also of technical expertise. Requirements for a successful production run should be developed with an experienced CMO partner familiar with potential issues and capable of providing expected levels of client satisfaction.
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