International journal of pharmaceutical compounding最新文献

Objective: A male health outcomes investigator, in age bracket 55 - 65, with BMI = 27 kg/m2, but without type 2 diabetes, took compounded tirzepatide 7.5 mg/week therapy as an experiment to see if he could achieve a 10% reduction in body weight over approximately four weeks and restore BMI = 25 kg/m2. Secondary endpoints included maintenance of weight-lifting strength, maintenance of speed and endurance in lap swimming, and maintenance of a nutrient-dense vegan diet. This study was undertaken to address some of the claims currently circulating in popular media about tirzepatide and the glucagon-like peptide 1 receptor agonist (GLP-1 RA) class of injectable drugs. All previous medical journal articles that mention the active pharmaceutical ingredient (API) tirzepatide have referred to the branded drug, while this article is the first one focused on compounded tirzepatide.

Methods: The investigator received weekly subcutaneous injections of 7.5 mg compounded tirzepatide over four weeks at a cost of $400 for four prefilled syringes. In the first, third, and fourth weeks, the investigator received 7.5 mg of compounded tirzepatide as a bolus injection. In week 2, the 7.5 mg dose was distributed over two injections of approximately 3.75 mg each given two days apart. The investigator recorded any lifestyle changes or changes in eating habits that resulted from this short duration study on the effects of tirzepatide for weight loss.

Results: With four weeks of compounded tirzepatide therapy, the investigator achieved a 5% reduction in body weight and a BMI of 25.8. Despite continuing to participate in daily exercise, having a healthy vegan diet, and supplementing with many vitamins, minerals, electrolytes, and nutrient-dense foods, the investigator regained 5% body weight within two weeks after the conclusion of the study. The investigator experienced side effects similar to those reported for GLP-1 RA class of injectable drugs, including tirzepatide. However, the treatment revealed an undulating pattern in which the compounded tirzepatide injection produced the desired effects, but intermittently the patient experienced neither a sense of satiety nor a sense of delayed digestion post injections, therefore, ate a normal meal and/or snacks. Adverse events included generalized bloating and flatulence, carbohydrate-specific temporary weight gain and bloating, intestinal rapid emptying comparable to excessive laxative use, and profound thirst with water consumption approximately double his normal level. Weight-lifting strength was maintained across a wide variety of equipment stations; lap swimming speed was maintained, and endurance was increased on compounded tirzepatide therapy. Apparent negative and positive neuroplasticity in the study period enabled the investigator to overcome a craving for one high caloric sugary snack, and to overcome an endurance barrier in the laps swam per set and

The direct importation of Active Pharmaceutical Ingredients (APIs) presents significant opportunities for compounding pharmacies to optimize costs and expand their services. However, sourcing APIs from foreign manufacturers, particularly from countries like China, introduces complex regulatory challenges. This article examines the federal regulatory framework governing API importation, outlines due diligence measures that compounding pharmacies should undertake, and provides general guidance on state-level considerations. By adhering to these guidelines, compounding pharmacies can mitigate risks, better ensure compliance with applicable laws and regulations, and maintain the integrity of their compounding practices.

Alopecia encompasses various forms of hair loss, including autoimmune conditions like Alopecia Areata, genetic patterns like Androgenetic Alopecia, and temporary issues like Telogen Effluvium. Treatment options vary based on the type and may include medications and topical solutions like TrichoSol™, which enhances hair growth through specialized technology. Personalized medicine and compounding pharmacies are crucial in tailoring treatments to individual needs. This study evaluates the safety and efficacy of TrichoSol™ with multiple active ingredients to support its use in compounded alopecia therapies. For this purpose, compatibility studies were performed using stability-indicating methods to determine the beyond-use dates (BUDs) of compounded formulations within TrichoSol™. The results demonstrates that: metronidazole, caffeine, and triamcinolone are stable for 180 days; 17-a-estradiol is stable for 150 days, while spironolactone lasts 120 days; clobetasol propionate is stable for 90 days, and both finasteride, tretinoin, and melatonin are stable for 60 days in TrichoSol™, all at room temperature. Therefore, TrichoSol™ offers a practical compounding vehicle for these active pharmaceutical ingredients in a liquid topical formulation.

Hardshell capsules are favored in individualized formulations due to their flexibility and convenience. However, excipient selection is crucial to ensure the active pharmaceutical ingredient (API) maintains stability, compatibility, and efficacy. Excipients, while typically inert, play a vital role in enhancing the manufacturing process, stability, and dissolution of APIs. Fagron's DiluCap® line is composed of six functional excipients designed to optimize capsule formulations. This study evaluates the dissolution profiles of hard-shell capsules containing minoxidil (1 mg and 2.5 mg) in DiluCap® SLD, finasteride (1 mg and 5 mg) in DiluCap® PSD, minoxidil + finasteride (2.5 mg + 1 mg) in DiluCap® SLD, melatonin (2 mg) in DiluCap® SR, and naltrexone (1.5 mg) in DiluCap® SR. Dissolution tests were conducted under gastrointestinal-simulating conditions. Minoxidil and finasteride capsules achieved rapid dissolution, while melatonin and naltrexone capsules demonstrated controlled release, highlighting the suitability of DiluCap® excipients for multiple purposes in compounding pharmacies. The findings underline the importance of selecting appropriate excipients to ensure API performance, enhance bioavailability, and streamline compounding processes.

This study investigates the potential of using kappa-carrageenan and hydroxypropylated tapioca starch as alternatives to traditional gelatin capsules in pharmaceutical applications. Nine formulations are developed and optimized based on viscosity, appearance, and loss on drying. The process involves a rotary die method for encapsulation, followed by characterization including SEM analysis, moisture content, and stability assessment. The optimized formulation (F8) demonstrates clear description, appropriate viscosity (11035 cps), and acceptable loss on drying (33.5%). Physical characterization reveals consistent capsule dimensions and moisture content within acceptable ranges. Disintegration and drug release studies indicate promising performance, with capsules dissolving within 15 minutes and achieving 99.23% drug release in 60 minutes. Stability testing confirms the suitability of the optimized formulations for pharmaceutical use.

Selecting an appropriate sanitizer (i.e., "rub") for application to hands and gloves before and, if necessary, during sterile compounding is as important as is its consistent and judicious use. Alcohols and chlorhexidine gluconate, which have long been recognized as safe and powerful biocides, are often essential ingredients in such sanitizing products. In this second article in a 2-part series on alcohol-based hand and glove sanitizers, we review the selection of and need for those rubs in sterile compounding, present considerations for their safe storage, compare the features of several appropriate sanitizing agents, and answer compounders' frequently asked questions about their use. Glove sanitizing is discussed as part of the hand-sanitizing process. In part 1 of this series, we explained, among other topics, the mechanism of action and composition of alcohol-based sanitizers and presented a protocol for their application to hands and gloves.