International journal of pharmaceutical compounding最新文献

{"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}

{"title":"Prescription - Transparency and the Evolution of Compounding.","authors":"Thomas C Kupiec","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Ten years after the passage of Section 503B of the Drug Quality and Security Act, outsourcing facilities have become an embedded part of the compounding landscape. Pharmacies of all types 503A, 503B, hospital, investigational) are working not only to meet new standards but to define how those standards translate into consistent, high-quality care. From non-sterile and sterile formulations to microbial preservative and novel delivery systems, adaptation is no longer optional. It is a daily discipline.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 3","pages":"180"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527946","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":"Microbial Challenge of Stable Compounded Clozapine Suspensions in Plastic Bottles.","authors":"Jessica Berzy, Hanif Sachedina, Arif Virji, Jason A Gross, Erica Cull, Scott E Walker","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background and rationale: </strong>A clozapine oral suspension is not commercially available in Canada and is required for administration to patients who cannot swallow intact tablets. While a stable formula has been described, no studies document the effectiveness of the preservative system used in this formulation to control inadvertent microbial contamination by the user during use of the preparation.</p><p><strong>Objective: </strong>The objective of this study was to evaluate the antimicrobial effectiveness of 25-mg/mL and 50-mg/mL oral suspension of clozapine after 120-days of storage at 20o-25oC, ensuring a compounded clozapine preparation can be provided to a patient with confidence and supporting the beyond-use-date of the preparation.</p><p><strong>Methods: </strong>The USP Chapter <51> Preservative Effectiveness Test protocol was followed as described for category 3 products. After storage for 120-days at 20o-25oC in amber glycol-modified polyethylene terephthalate (PET-G), both the 25-mg/mL and 50-mg/mL clozapine suspensions were inoculated with 3 different strains of bacteria and 2 strains of fungi and incubated for 28-days. On days 7, 14 and 28, the bacterial and fungal colony counts determined the antimicrobial effectiveness of the suspension. The suitability of the microbial recovery method was validated prior to completing the challenge test.</p><p><strong>Results: </strong>The microbial load of the clozapine suspensions declined from an initial CFU count between 105-106 to less than 10-CFU by day 7 for bacteria and less than 30-50 CFU for yeast & fungi. On days 14 and 28, the bacteria showed no changes from counts at day 7th, while the yeast & fungi declined to less than 10 CFU. This indicates effective antimicrobial activity of the clozapine oral suspension.</p><p><strong>Conclusions: </strong>The 25-mg/mL and 50-mg/mL clozapine suspensions have been demonstrated to effectively control bacterial and fungal contamination, as judged by the USP Chapter <51> Antimicrobial Effectiveness Test. This bracketed formulation has been previously demonstrated to retain more than 95% of its initial active concentration when stored at 4oC or 25oC for 120-days.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 3","pages":"194-201"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527942","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":"Personalized Compounded Hair Loss Treatments: A Compatibility Assessment of the TrichoConcept™ Vehicle Line.","authors":"Carolina Schettino Kegele, Bruna Marianni, Hudson Caetano Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Personalized medicine has become a crucial approach in dermatology, particularly in the treatment of androgenetic alopecia (AGA) and other scalp conditions. This study evaluates the compatibility of the TrichoConcept™ line - comprising TrichoSol™, TrichoFoam™, TrichoWash™, and TrichoCond™ - as vehicles for active pharmaceutical ingredients (APIs) commonly used in alopecia treatment, including biotin, caffeine, finasteride, fluocinolone, ketoconazole, melatonin, minoxidil, niacinamide, prostaquinon, pyridoxine, and tretinoin. High-performance liquid chromatography (HPLC) and forced degradation studies were conducted to assess physicochemical stability. The results indicate that F1 (biotin 0.5%, caffeine 2.0% and niacinamide 2.0% in TrichoCond™) and F3 (caffeine 2.0%, melatonin 2.0% and pyridoxine 0.5% in TrichoCond™) remained stable for 180 days, while F2 (finasteride 0.1%, minoxidil 1.0% and tretinoin 0.01% in TrichoSol™) was stable for 14 days. Additionally, F4 (fluocinolone 0.01% and ketoconazole 2.0% in TrichoWash™) and F5 (minoxidil 7.0%, tretinoin 0.02% in TrichoCond™) showed stability for 150 days. F6 and F7 (prostaquinon 3.0% in TrichoSol™ and TrichoFoam™, respectively) showed stability for 180 days. These findings support the use of the TrichoConcept™ line as a reliable vehicle for customized hair loss treatments, enhancing both therapeutic outcomes and patient adherence.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 3","pages":"239-253"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527944","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":"Advertising and Marketing for Compounding Pharmacies: Many Shades of Grey.","authors":"Amanda F Hobbs, Brad Howard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>While the advertising of FDA approved prescription drugs is highly regulated and clear guidelines are abundant, the limitations on allowable advertising for compounded medications are oblique, confusing, and inconsistently enforced. As a result, many compounding pharmacies find themselves taking an overly conservative approach out of fear of enforcement actions, while others step too boldly, seeking forgiveness rather than permission. This article explores both the historical reasons for the surprising level of ambiguity and uncertainty in the advertising of compounding pharmacies, as well as some helpful guidelines for developing compliant ads and appropriately assessing the risk of enforcement actions.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"104-110"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752622","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":"Current Problems of Pharmaceutical Compounding in Hungary.","authors":"Szabolcs Dobson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>On average, at least about 85-90% of compounded (magistral) medicinal products are prescribed by doctors in Hungary on an individual basis, outside the official National Formulary of compounded medicinal products (Formulae Normales or FoNo). Until now, the problem has been that no one has had a comprehensive understanding of the domestic non-FoNo compounded medicinal products, so the authorities have not been able to issue detailed regulations to address typical problems. However, from the database www.magisztralisvenyek.hu, available since 2020, the characteristics and typical errors of compounding can be well studied. In the absence of reforms, the field of compounded medicinal products in Hungary has become very outdated compared to some developed countries (especially Germany) and has entered a crisis. Doctors are prescribing a lot of compounded products of unproven efficacy, safety and stability. The Author gives an overview of the characteristics and problems of some groups of non-FoNo compounded preparations, describes the historical reasons for the current situation and proposes a reform of compounding.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"96-103"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752691","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":"Erratum - Physical Compatibility of Cefiderocol with Selected Intravenous Drugs During Simulated Y-site Administration.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In the article \"Physical Compatibility of Cefiderocol with Selected Intravenous Drugs During Simulated Y-site Administration,\" [Reference: Int J Pharm Compd. 2021; 25 (1): 52-61.] Table 1, row 33 states that the challenge drug was \"Total Parenteral Nutrition, Hospira (Lot 87-308-DK).\" This challenge drug description should be corrected to \"TPN Electrolytes, Hospira (Lot 87-308-DK).</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"121"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752692","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}