International journal of pharmaceutical compounding最新文献

{"title":"Legal Challenges to Compounding Drugs for Weight Loss.","authors":"Blinn E Combs, Brad Howard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Over the last three years, a combination of wildly growing demand and near-constant shortages have provided both compounding pharmacies and outsourcing facilities with strong financial incentives to move aggressively into the production and sale of semaglutide and tirzepatide. Although for simplicity's sake, we focus on semaglutide, broadly similar remarks apply to tirzepatide. This lucrative market has also proved very tempting to physicians working in the weight loss space. The fact that the predominant use of these drugs-to aid weight loss-is not typically covered by insurance, has sweetened the proverbial pot. Because reimbursement is not typically tied to federal health care programs, there is less risk from the attendant federal legal prohibitions on kickbacks and physician self-referral. Nevertheless, both compounders and clinical practices currently face significant legal risks from avoiding the branded products in favor of compounding and selling analogous drugs. We review some of the relevant history for semaglutide, including the regulatory framework and an overview of the additional risks of this novel trend in the compounding space. We should note at the outset that the following is only a cursory overview of the risks, which vary significantly and evolve rapidly. If you are considering compounding these drugs, you should seek jurisdiction specific advice from competent legal counsel.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 4","pages":"267-278"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080701","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":"Stability Study of Pediatric Oral Suspensions Formulated with PCCA SuspendIt Vehicle Used for the Treatment of Cardiovascular Disease.","authors":"Courtaney Davis, Kendice Ip, Daniel Banov, Oleksandr Zdoryk","doi":"","DOIUrl":"","url":null,"abstract":"&lt;p&gt;&lt;p&gt;The pharmaceutical landscape in pediatric cardiology involves the use of several key active pharmaceutical ingredients (APIs) that have been carefully selected to address the diverse range of conditions encountered. Hydrochlorothiazide, captopril and metoprolol are part of this list, selected based on stringent criteria that included proven efficacy, a favorable safety profile, and suitability for pediatric use. These active ingredients belong to different pharmacological groups - an angiotensin-converting enzyme inhibitor (captopril), a thiazide diuretic (hydrochlorothiazide) and a beta-blocker (metoprolol) - and are used to treat a variety of cardiovascular problems. Commercial pharmaceutical forms of these drugs are not available for pediatric patients, leaving a gap in dosing options. Therefore, the primary means of serving this population is through extemporaneous compounding of suspensions using pure drug powder or commercial tablets. The objective of this study was to investigate the physicochemical and microbiological stability of three distinct compounded pediatric oral cardiovascular suspensions, that contain captopril, hydrochlorothiazide, and metoprolol tartrate, and are formulated using PCCA SuspendIt. The study design included two concentrations of each API to provide stability investigation over a bracketed concentration range: captopril (1 mg/mL and 5 mg/mL), hydrochlorothiazide (5 mg/mL and 10 mg/mL), and metoprolol (1 mg/mL and 10 mg/mL). Ultra-high-performance liquid chromatography (UHPLC) methods were developed and validated for the determination of the chemical stability of captopril, hydrochlorothiazide, and metoprolol in SuspendIt. Samples of hydrochlorothiazide and metoprolol suspensions were stored in plastic amber prescription bottles at the temperature 25±2 °C, relative humidity 60±5 %, and captopril suspensions at 5±3 °C. Samples were analyzed at the following time points: 0, 7, 14, 30, 60, 90, and 180 days. Various forced degradation conditions were employed, including acidic, basic, oxidative, and heat degradation. The results revealed that potential interfering degradants do not affect the analytical peaks of the drug substance, and the factors contributing to the significant degradation of the drug substance in the suspension were identified. Physical properties such as pH and appearance were also observed. All measurements were performed in duplicate. Antimicrobial efficacy tests were performed to control microbial growth during storage. The current study demonstrates that SuspendIt cardiovascular suspensions are physically, chemically and microbiologically stable for 180 days for captopril (when stored in the refrigerator) and hydrochlorothiazide and metoprolol tartrate (when stored at room temperature), retaining not less than 90% of the labeled drug concentrations. This study provides a viable compounded alternative for hydrochlorothiazide, metoprolol tartrate and captopril in a liquid dosage form with an","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 4","pages":"279-290"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080747","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":"Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4.","authors":"Carolina Schettino Kegele, Eli Dijkers, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Many psychiatric and neurological medications lack commercial liquid formulations, requiring extemporaneous compounding for patients unable to swallow solid dosage forms. While chemical stability data support extended beyond-use dating for various APIs in SyrSpend® SF PH4, antimicrobial effectiveness data essential for USP <795> compliance remain limited. To evaluate antimicrobial effectiveness and physicochemical stability of seven commonly compounded psychiatric and neurological drug suspensions in SyrSpend® SF PH4 to support evidence-based beyond-use dating decisions. Suspensions of amitriptyline hydrochloride (10.0 mg/mL), clonazepam (0.2 mg/mL), haloperidol (0.5 mg/mL), lorazepam (1.0 mg/mL), naltrexone hydrochloride (1.0 mg/mL), pregabalin (20.0 mg/mL), and sertraline hydrochloride (10.0 mg/mL) were prepared and stored at ambient and refrigerated conditions. USP <51> antimicrobial effectiveness testing was conducted alongside pH and visual appearance assessments. All formulations achieved USP <51> bacterial reduction criteria for E. coli, P. aeruginosa, and S. aureus. Complete C. albicans control was demonstrated in all formulations. A. brasiliensis showed variable responses, with persistent counts in naltrexone, pregabalin, and sertraline formulations, though remaining within USP acceptance limits. pH stability was maintained (3.3 - 5.1) with no visual changes observed. Storage temperature did not significantly affect stability. Results support beyond-use dating recommendations for all APIs at all conditions. These evidence-based recommendations provide compounding pharmacists with USP-compliant guidance for safe extended beyond-use dating while maintaining appropriate safety margins for pediatric, geriatric, and other vulnerable populations.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 4","pages":"319-327"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080709","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":"Compounding Pharmacists: Key Educators on Timolol Nasal Spray for Acute Migraine.","authors":"John C Hagan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The great majority of physicians treating migraine are not using this very successful compounded timolol nasal spray. In this review I shall briefly cover the development of compounded nasal spray timolol; and explain why you should educate your discontented migraine patients about nasal spray timolol that is only available from compounding pharmacists.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 4","pages":"259-266"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080674","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":"Calendula: General Aspects, Applications, and Formulations in the Pharmaceutical Industry.","authors":"Jorge Andrés Pacheco Molina, Arlene Loría Gutierrez, Jeimy Blanco Barrantes, Daniela Matarrita Brenes, Maripaz Santamaría Muñoz, German Madrigal Redondo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Calendula plant has been used in traditional medicine for its purported healing properties in various ailments. These properties are due to different chemical components present in the plant, such as flavonoids and carotenoids. In this review, articles from 2011 to 2023 were surveyed to determine important phytochemicals present in calendula, as well as the parts of plant where each of these predominate. The pharmacological effects are attributed to constituents of calendula, and their use in formulations are described to show potential of calendula as a therapeutic agent.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 4","pages":"301-309"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080754","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":"Antimicrobial Stability, pH, and Physical Appearance of Cardiovascular Drug Suspensions in SyrSpend® SF PH4: A Complementary Evaluation.","authors":"Carolina Schettino Kegele, Eli Dijkers, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The compounding of extemporaneous oral liquid formulations is essential for personalized pharmacotherapy, particularly for pediatric, geriatric, and dysphagic patients who require tailored doses and flexible dosage forms. However, preservative-free liquid vehicles require thorough evaluation to ensure antimicrobial safety and physicochemical integrity over time. This complementary study aimed to assess the antimicrobial effectiveness, pH stability, and physical appearance of cardiovascular drug formulations prepared with SyrSpend® SF PH4 liquid, in order to support beyond-use dating (BUD) in compliance with United States Pharmacopeia (USP) standards. The pH and appearance were monitored at predefined intervals over 90 days under room temperature (25 ± 2°C) and refrigerated (5 ± 3°C) storage conditions, and the antimicrobial effectiveness was evaluated following the USP <51> protocol at the end of this period. Nine oral formulations of seven cardiovascular drug suspensions were included: amlodipine (as besylate) 1.0 mg/mL, enalapril maleate 1.0 mg/mL, hydrochlorothiazide 2.0 and 5.0 mg/mL, lisinopril (as dihydrate) 1.0 mg/mL, metoprolol tartrate 10.0 mg/mL, pentoxifylline 20.0 mg/mL, and spironolactone 2.0 and 2.5 mg/mL. All formulations met USP criteria for antimicrobial effectiveness, while maintaining stable pH values and no relevant changes in physical appearance throughout the study. These results, when combined with previously demonstrated chemical stability (HPLC), confirm that SyrSpend® SF PH4 is a robust and reliable vehicle for preservative-free extemporaneous oral liquid formulations, supporting its safe use within USP-compliant BUD limits.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 4","pages":"310-318"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080756","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":"One Decade In and Counting: How 503B Outsourcing Facilities Are Finding Their Place in the Industry.","authors":"Michael R Alexander, Blinn E Combs, Brad Howard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>It has been just over a decade since Congress passed the Drug Quality and Security Act of 2013, creating \"outsourcing facilities\" through the addition of Section 503B to the Federal Food, Drug, and Cosmetic Act.1 Since its passage, approximately 90 outsourcing facilities have registered with the FDA. Practitioners, pharmacies, clinics, and other industry participants have begun to incorporate the services outsourcing facilities provide into their business practices. As outsourcing facilities have opened, the market has had to feel out what role these facilities play in the industry. So where do things stand now, and what does the future hold for outsourcing facilities and their place in the healthcare market?</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 3","pages":"182-189"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527943","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":"Physicochemical and Microbiological Stability of Commonly Prescribed APIs in SyrSpend® SF PH4: A Comprehensive Compatibility Study.","authors":"Carolina Schettino Kegele, Eli Dijkers, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>SyrSpend® SF PH4 is a preservative-light, starch-based oral suspending vehicle formulated for personalized medicine in vulnerable populations such as pediatric and geriatric patients. This study evaluated the physicochemical and microbiological stability of eleven active pharmaceutical ingredients (APIs) compounded in SyrSpend® SF PH4 (liquid and dry forms). The following formulations were tested: azithromycin (40.0 mg/mL), bismuth subsalicylate (17.5 mg/mL), budesonide (0.25 mg/mL), buspirone (2.5 mg/mL), cephalexin (50.0 mg/mL), chlorpromazine hydrochloride (100.0 mg/mL), citalopram hydrobromide (2.0 mg/mL), cyanocobalamin (0.2 mg/mL), famotidine (8.0 mg/mL), meloxicam (0.2 mg/mL), and orphenadrine citrate (5.0 mg/mL). Each formulation was stored under refrigerated (2-8°C) and room temperature (20-25°C) conditions, then evaluated over 90 days using validated ultra-high-performance liquid chromatography (UHPLC) and antimicrobial effectiveness testing (AET) per USP <51>. Azithromycin was not stable at room temperature but maintained stability for 60 days under refrigeration; bismuth subsalicylate remained stable for 14 days under both storage conditions; cephalexin remained stable for 14 days at room temperature and 30 days refrigerated; budesonide, buspirone, chlorpromazine hydrochloride, citalopram hydrobromide, cyanocobalamin, famotidine, meloxicam, and orphenadrine citrate all demonstrated stability for 90 days under both conditions. AET confirmed microbial control throughout the storage period for all samples. These results confirm that SyrSpend® SF PH4 is a reliable vehicle for extemporaneous compounding of a broad range of oral liquid formulations, offering extended BUDs for most APIs tested. Its excipient profile - free from harmful substances like alcohol, parabens, propylene glycol, and sorbitol - supports safe use in pediatric and geriatric patients. The study provides evidence-based guidance for pharmacists in assigning appropriate BUDs and optimizing personalized therapy through compounded oral suspensions.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 3","pages":"222-238"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527945","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 Non-Sterile Containment Ventilated Enclosures.","authors":"David Wasescha","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Maintaining the safety and efficacy of non-sterile compounding CVEs requires ongoing diligence and a proactive approach to compliance. By regularly confirming the functionality and certification of your CVEs, adhering to best practices for usage, and staying on top of necessary maintenance, you can ensure a culture of safety that protects your patients and pharmacy personnel, while ensuring your compounding equipment lasts for years.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 3","pages":"190-193"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527940","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 Optimization of Novel Antiaging Polyherbal Liposal Gel Using Central Composite Design.","authors":"Mathew Amalu, Mariate B Roshita, George Honeymol, Tina J, Jojo M Gifty","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A formulation for preparing Formulation and Optimization of Novel Antiaging Polyherbal Liposal Gel Using Central Composite Design. Includes ingredients, method of preparation, discussion, and references for the compounding pharmacist.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 3","pages":"210-221"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527941","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}