International journal of pharmaceutical compounding
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The case report discussed in this article illustrates the painful endeavor of a patient who suffered from severe peripheral neuropathic pain and the to-and-from treatment adjustments that are needed before an optimal grade of pain control and an acceptable quality of life could be achieved. The next to optimal treatment was obtained by meticulously adjusting drugs and combining systemic drugs with topical ones. Compounding pharmacists play an important role in offering potent topical preparations that give an important analgesic added value to complex treatments.
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The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U. ⋯ Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.
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Compounding pharmacies that compound sterile preparations must choose sterile filters that are approved for human use. They may rely on the filter manufacturer's Certificate of Quality to ensure the sterile filter is pyrogen free and has been tested for bacterial retention. The Certificate of Quality from the filter manufacturer also contains other useful information about the filter such as: flow rate and maximum pressure drop, thermal and hydraulic stress, and membrane results of the initial integrity test performed on the filter membrane with water, if a hydrophilic membrane. This article discusses the integrity test, which is often called the water bubble point test.
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No matter the profession, professionals should never stop learning. This is especially true and important in the profession of compounding pharmacy. ⋯ As compounding pharmacists learn, be it through formal continuing education or experience, they should be willing to share their knowledge with other compounders. In our goal of providing compounding pharmacists with additional knowledge to improve their skills in the art and practice of compounding, this article, which provides tips and hits on compounding with powders, capsules, tablets, suppositories, and sticks, represents the first in a series of articles to assist compounding pharmacists in the preparation of compounded medications.