Every Fifth Extemporaneously Manufactured Dosage Form Does Not Meet The Targeted Strength Criteria

Veterinary drug treatment is often challenging due to size and body mass variations, as well as pharmacokinetic inter-species variability. The availability of approved veterinary products is relatively small, consequently leading to the need for extemporaneous manufacturing. There are several ways to define the practice of the extemporaneous preparation of medicines. In this article, the term extemporaneous manufacturing will be used, but it may also be referred to as extemporaneous preparation, extemporaneous compounding, or simply compounding. Generally, extemporaneous manufacturing is necessary when a therapy cannot be provided by commercially available products to a specific patient. By extemporaneous manufacturing, dosage forms that may be easier for a pet to tolerate and for an owner to administer can be provided, thus encouraging compliance. Mixing two or more approved drug products together into a single dosage form, changing the dosage form of an approved drug product, adding patient-preferred flavoring to an approved drug product, or preparing a dosage from bulk ingredients are all considered extemporaneous manufacturing. European Pharmacopoeia defines extemporaneous preparations as pharmaceutical preparations that are individually prepared for a specific patient or patient group and supplied to the patient after preparation. In contrast, stock preparations are prepared in bulk in advance and stored until needed. Extemporaneous manufacturing generally takes place at pharmacies in accordance with the prescription provided by a licensed veterinarian.

 There are benefits when it comes to the extemporaneous manufacturing of veterinary drug therapies, but there are also risks. These risks are due to preparation errors, contamination, chemical and physical stability, and a lack of bioavailability in the target patient. As an example, The Missouri Board of Pharmacy annually tests and reports extemporaneously manufactured drug preparations from Missouri licensed pharmacies. In Table 1, the results obtained between the years 2006–2019 are gathered. The Missouri Board of Pharmacy has considered an acceptable potency range of +/−10% of the expected potency unless a USP monograph states a different range for specific preparations. The results indicate that every fifth extemporaneously manufactured dosage form does not meet the targeted strength criteria. Analyzed potencies ranged from not containing any active ingredient at all (years 2006 and 2009) up to a potency of 450.4% (the year 2007). To assure the quality of the produced drug doses, quality assurance should be implemented for extemporaneously manufactured doses.

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This article has been published in Applications of Additive Manufacturing in Pharmaceutics

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https://www.mdpi.com/1999-4923/12/12/1239/htm#B3-pharmaceutics-12-01239