International journal of pharmaceutical compounding最新文献

{"title":"Compatibility of Active Pharmaceutical Ingredients Combinations Compounded in Cleoderm™, a Cream Base for Personalized Dermatological Treatments.","authors":"Bruna Marianni, Carolina Costa Vicente Silva, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The increasing prevalence of skin conditions like acne, rosacea, and hyperpigmentation highlights the need for personalized dermatological treatments, with compounded formulations providing tailored solutions by combining multiple active pharmaceutical ingredients (APIs). This study evaluates the compatibility and stability of various formulations compounded in Cleoderm™, a cream base designed for acne-prone, affected, or sensitive skin. The tested formulations included: adapalene 0.1% or 0.3% and benzoyl peroxide 1.0% or 5.0%; hydroquinone 4.0%, hydrocortisone 1.0%, and tretinoin 0.0125%; azelaic acid 15.0% or 20.0% and niacinamide 4.0%; niacinamide 4.0% and tretinoin 0.025%; and clindamycin hydrochloride 3.0%. Each formulation underwent high-performance liquid chromatography (HPLC) and microbiological assessments over a 180-day period to determine stability and beyond-use dates (BUDs). Both formulations containing adapalene and benzoyl peroxide demonstrated excellent stability, with an assigned BUD of 180 days. Formulations of azelaic acid combined with niacinamide and niacinamide with tretinoin also showed sustained stability with BUDs of 180 days. In contrast, the formulation containing hydroquinone, hydrocortisone, and tretinoin had a BUD of 14 days. Clindamycin hydrochloride displayed a similar pattern, with stability maintained for 14 days. Microbiological evaluations confirmed the antimicrobial efficacy of all formulations, meeting United States Pharmacopeia (USP) requirements for antimicrobial effectiveness throughout their respective BUDs. The findings underscore the importance of evaluating the stability and compatibility of compounded formulations to ensure their safety and efficacy. This study supports the use of Cleoderm™ as a versatile and reliable base for personalized dermatological treatments, providing evidence-based BUDs to guide clinical practice.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"150-162"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation and Characterization of Ophthalmic in Situ Gel Forming Solution of Timolol Maleate for Glaucoma.","authors":"Kumaravelrajan Rajagopal, Gokul Kanmani, Suba Venkatesan, Amudha Palanivelu","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This study comprehensively investigates the physicochemical properties and performance of ophthalmic formulations containing timolol maleate with different polymers. Fourier-transform infrared (FTIR) spectroscopy revealed distinct spectral changes, indicating interactions between timolol maleate and Hydroxyethyl Cellulose (HEC), Xanthan gum, and Gellan gum. Clarity assessments confirmed transparency against white and black backgrounds. pH measurements ensured physiological compatibility (HEC: pH 6.90, Xanthan gum: pH 6.97, Gellan gum: pH 6.98). Evaluation of gelling capacity and strength highlighted Xanthan gum's superiority (Xanthan gum: 180 Pa, Gellan gum: 153 Pa). Viscosity studies demonstrated suitability for ocular use, with pre-gelling values of HEC: 100.11 cps, Xanthan gum: 112.55 cps, Gellan gum: 110.42 cps, and post-gelling values of HEC: 100.01 cps, Xanthan gum: 256.22 cps, Gellan gum: 206.21 cps. Osmolality aligned with ophthalmic norms (HEC: 272 mOsm/kg, Xanthan gum: 290 mOsm/kg, Gellan gum: 285 mOsm/kg). In vitro drug release profiles varied, with Xanthan gum showing sustained release (95.01% over 8 hours). Rabbit eye irritation studies confirmed safety. Stability assessments over three months validated consistent attributes, supporting their potential as effective ophthalmic formulations.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"132-140"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Best Practices When Compounding FDA-Approved Drugs Listed in Shortage.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 1","pages":"22-27"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Compounded Tirzepatide Therapy for Weight Loss: A Health Economics & Outcomes Research (HEOR) Analysis.","authors":"Michael As Guth","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 ","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 1","pages":"52-63"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navigating the Direct Importation of Active Pharmaceutical Ingredients: Compliance Considerations for Compounding Pharmacies.","authors":"Bradley S Byars, Brad Howard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 1","pages":"6-13"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Compatibility of 17-a-estradiol, Caffeine, Clobetasol Propionate, Finasteride Melatonin, Metronidazole, Spironolactone, Tretinoin, and Triamcinolone in Trichosol, a Natural Vehicle for Hair Solutions.","authors":"Carolina Schettino Kegele, Bruna Marianni, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 1","pages":"64-76"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Best Practices for Marketing Compounded Medications.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 1","pages":"28-32"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Compounded GLP-1 Drugs and Patient Adverse Events.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 1","pages":"33-36"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standard Operating Procedure: Calculating the Endotoxin Load in Compounded Sterile Preparations.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 1","pages":"38-39"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biopharmaceutical Performance of DiluCap: A Line of Functional Excipients Enhancing Dissolution Profiles of Minoxidil, Finasteride, Melatonin, and Naltrexone.","authors":"Carolina Schettino Kegele, Anderson de Oliveira Ferreira, Savvas Koulouridas, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 1","pages":"77-84"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}