International journal of pharmaceutical compounding最新文献

{"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}

{"title":"Long-term Physicochemical Stability of a Pharmaceutical Preparation of Morphine Hydrochloride and Droperidol in Polypropylene Syringes.","authors":"Amandine Nobels, Mélanie Closset, B Bihin, Jacques Jamart, Laura Soumoy, Louise Lombet, Jean-Daniel Hecq, Laurence Galanti, Marie-Lise Colsoul, Emilie Catry","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to investigate the physicochemical stability of morphine hydrochloride and droperidol mixture stored in polypropylene syringes to prepare them in advance by a centralised intravenous additive service (CIVAS).</p><p><strong>Methods: </strong>Five polypropylene syringes containing 2 mg/mL morphine hydrochloride and 0.083 mg/mL droperidol were stored in a light-protected environment at room temperature. The physical and chemical stability of solutions was periodically evaluated over a 50 days-period. The samples were visually and microscopically examined, the absorbance at three different wavelengths (350, 410, and 550 nm) and the pH were measured. An ultra-high performance liquid chromatography-photodiode array detection (UHPLC-PDA) method was developed and validated to determine the concentrations of these two drugs simultaneously.</p><p><strong>Results: </strong>Over the course of the 50-days evaluation, no observable change in colour, particle or crystal formation was detected in any of the samples by visual and microscopic examinations. The pH and absorbance at only 350 nm exhibited a slight upward trend over time in all five syringes. Regarding the chemical stability, the lower limit of the one-side 95 percent prediction interval (LL95PI) remains above 90% of the initial mean concentration for the five syringes.</p><p><strong>Conclusions: </strong>The pharmaceutical preparation of 2mg/mL morphine hydrochloride and 0.083 mg/mL droperidol in polypropylene syringes, stored in a light-protected environment at room temperature, displayed stability throughout the 50-days study period. It is noteworthy that even there were slight variations in pH and absorbance at 350 nm, these observations, to the best of our knowledge, do not contraindicate the preparation of this admixture in advance under aseptic conditions by a CIVAS. However, the compounding process must be validated for sterility, accuracy and reproducibility.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"141-149"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752695","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":"New USP Chapters <72> and <86> for Testing Pharmaceuticals for Sterility and Endotoxins.","authors":"Lisa D Ashworth","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The pharmaceutical industry has been moving towards medications and tests that are not animal derived or have animal components for many years, for several reasons (e.g., diseases in animals, shortage of the animal or animal body part the substance is derived from). It can be a slow or fast process to move from an animal derived substance to producing a synthetic version depending on the substance and the public health need.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"116-119"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752696","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":"Let's Talk About Outside Sales Reps for Compounding Pharmacies.","authors":"Jerrod Roberts","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Hiring an outside sales representative for your compounding pharmacy-have you ever considered it? For many of us, it's been a game-changing move that expanded our each, grew revenue, and ultimately strengthened our businesses. But, like anything else, it's not a silver bullet. There are some serious advantages, but also challenges you'll need to navigate to get the most out of the investment. Let's break it down together.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"92-94"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752694","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":"Assessing the Compatibility of Different Formulations in OrPhyllo™, A Ready-to-Use Base for Personalized Orodispersible Films.","authors":"Bruna Marianni, Hudson Polonini, Savvas Koulouridas","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Orodispersible films (ODFs) represent a rapidly evolving dosage form that addresses significant challenges in drug delivery, particularly for patients with difficulty swallowing, such as pediatric, geriatric, and psychiatric populations. ODFs disintegrate rapidly on the tongue, eliminating the need for water and offering benefits such as improved patient compliance, faster onset of action, and enhanced bioavailability. This study evaluates the compatibility and beyond-use dates (BUDs) of 12 ODF formulations compounded in OrPhyllo™, a ready-to-use base specifically designed for ODF production. The active pharmaceutical ingredients (APIs) investigated were baclofen (5 and 10 mg), cetirizine (1.25 and 5 mg), coenzyme Q10 (10 and 50 mg), dextromethorphan (7.5 and 15 mg), ketoprofen (12.5 and 25 mg), loratadine (5 and 10 mg), meloxicam (5 and 20 mg), minoxidil (1 and 10 mg), ondansetron (2 and 8 mg), sildenafil (25 and 50 mg), tadalafil (5 and 20 mg), and tramadol (25 and 50 mg). Comprehensive compatibility studies were conducted to determine the BUD and physicochemical integrity of these formulations by using validated ultra-high-performance liquid chromatography (UHPLC) methods and following guidelines for accelerated and long-term stability testing. No Antimicrobial Effectiveness Testing (AET) was conducted as those are nonaqueous dosage forms. The formulations were stored at room temperature (15-30°C) for up to 180 days, individually packed in matte laminated aluminum sachets. Results revealed the following BUDs for each formulation: baclofen (5 mg - 10 mg): 180 days; cetirizine: 60 days; coenzyme Q10: 180 days; dextromethorphan: 180 days; ketoprofen (12.5 mg): 180 days; ketoprofen (>12 mg - 25 mg): 60 days; loratadine: 180 days; meloxicam: 180 days; minoxidil: 180 days; ondansetron (2 mg): 90 days; ondansetron (>2 mg - 8 mg): 30 days; sildenafil: 180 days; tadalafil: 180 days; tramadol: 150 days. These findings affirm the suitability of OrPhyllo™ as a robust vehicle for compounding ODFs, demonstrating compatibility with APIs across a broad spectrum of clinical applications.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"29 2","pages":"163-175"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752635","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}