International journal of pharmaceutical compounding最新文献_第2页

Chemical and Microbiological Stability of Extemporaneous Cardiovascular Suspensions Compounded in Dual Suspending Vehicle System. 双悬浮载具系统中临时心血管混悬液的化学和微生物稳定性。

International journal of pharmaceutical compounding Pub Date : 2026-05-01

Carolina Schettino Kegele, Sarah Taylor, Hudson Polonini

{"title":"Chemical and Microbiological Stability of Extemporaneous Cardiovascular Suspensions Compounded in Dual Suspending Vehicle System.","authors":"Carolina Schettino Kegele, Sarah Taylor, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"Extemporaneous compounding plays a critical role in providing individualized pharmacotherapy for pediatric patients who require cardiovascular medications not available in commercially manufactured liquid formulations. This study evaluated the chemical, physical, and microbiological stability of clopidogrel, hydrochlorothiazide, nifedipine, propranolol, and spironolactone oral suspensions prepared in Flavor Sweet™ SF/Flavor Plus™ (1:1) (also marketed in Europe as Syra Sweet SF/Syra Plus), a widely used vehicle in pharmacy compounding. All formulations were prepared using a standardized protocol and stored at room temperature and refrigerated conditions for up to 90 days. Stability-indicating UHPLC methods were validated and applied to quantify drug content and monitor pH and physical characteristics throughout the study. Antimicrobial Effectiveness Testing was performed in accordance with USP <51>. Hydrochlorothiazide, nifedipine, propranolol, and spironolactone retained 90-110% of labeled content for at least 90 days under both storage conditions, while clopidogrel showed temperature-dependent degradation and met stability criteria for up to 90 days only under refrigeration. All formulations maintained consistent pH values and exhibited no visual changes. Microbiological evaluation confirmed effective preservative performance across all samples, with no microbial proliferation and full compliance with USP <51> acceptance criteria.","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 3","pages":"269-285"},"PeriodicalIF":0.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603031","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}

引用次数: 0

Chemical and Microbiological Stability of Benazepril, Candesartan, Disulfiram, Fluconazole, Methocarbamol, and Pentoxifylline in SyrSpend® SF PH4. syspend®SF PH4中苯那普利、坎地沙坦、双硫仑、氟康唑、甲氨基酚和己酮茶碱的化学和微生物稳定性

International journal of pharmaceutical compounding Pub Date : 2026-05-01

Carolina Schettino Kegele, Eli Dijyers, Hudson Polonini

{"title":"Chemical and Microbiological Stability of Benazepril, Candesartan, Disulfiram, Fluconazole, Methocarbamol, and Pentoxifylline in SyrSpend® SF PH4.","authors":"Carolina Schettino Kegele, Eli Dijyers, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"This study evaluated the chemical and microbiological stability of six oral liquid formulations, benazepril hydrochloride, candesartan cilexetil, disulfiram, fluconazole, methocarbamol, and pentoxifylline, compounded in the suspending vehicle SyrSpend® SF PH4. Stability-indicating UHPLC methods were validated for each API and confirmed to be specific, precise, accurate, and linear within the analytical ranges tested. Forced degradation studies ensured method suitability for detecting potential decomposition pathways. Chemical stability was assessed over 90 days under room temperature and refrigerated storage, alongside pH monitoring and visual inspection. Antimicrobial effectiveness testing (USP <51>, Category 3: oral aqueous products) demonstrated that all formulations met preservative efficacy criteria at the final assigned BUD. Results revealed API-specific stability profiles: several formulations remained within 90-110% of label claim for up to 90 days, while others showed temperature degradation patterns dictating shorter BUDs. Overall, SyrSpend® SF PH4 proved to be a versatile and reliable vehicle for compounded oral liquids, supporting extended BUDs while maintaining physicochemical integrity and microbiological quality. These findings reveal dependent degradation patterns that dictate shorter BUDs. Overall, SyrSpend® SF PH4 proved to be a versatile and reliable vehicle for compounded oral liquids, supporting extended BUDs while preserving physicochemical integrity and microbiological quality. These findings provide evidence-based guidance for compounding pharmacists and reinforce the role of SyrSpend® SF PH4 in personalized pharmacotherapy.","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 3","pages":"235-268"},"PeriodicalIF":0.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603102","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}

引用次数: 0

Compliance Corner: Take Your Test Seriously with Respect to Reserve Samples Maintained in a 503B Outsourcing Facility. 合规角：认真对待在503B外包设施中维护的保留样品的测试。

International journal of pharmaceutical compounding Pub Date : 2026-05-01

Mala Cullipher

引用次数: 0

Evaluating the Utilization and Cost Analysis of High-dose Thiamine when Compounded or Administered Via Intravenous Push at an Academic Medical Center. 某学术医疗中心大剂量硫胺素复合或静脉推注的使用评估和成本分析。

International journal of pharmaceutical compounding Pub Date : 2026-05-01

Kaitlin Blotske, Brian Murray, Rob MacLaren, Scott Mueller, Shelby Pons, Garth Wright, Tyree H Kiser

{"title":"Evaluating the Utilization and Cost Analysis of High-dose Thiamine when Compounded or Administered Via Intravenous Push at an Academic Medical Center.","authors":"Kaitlin Blotske, Brian Murray, Rob MacLaren, Scott Mueller, Shelby Pons, Garth Wright, Tyree H Kiser","doi":"","DOIUrl":"","url":null,"abstract":"Purpose: Thiamine doses greater than 200 mg are typically prepared as an IV piggyback (IVPB) and administered over 30 minutes to reduce the risk of adverse events (AE) associated with administration. Administration of high-dose (HD) thiamine as an IV push may reduce cost and clinical burden without increasing risk of AE.Methods: This was a retrospective, single-center cohort analysis of hospitalized patients over the age of 18 years old admitted to the University of Colorado Hospital and receiving HD thiamine from June 1st, 2024 to October 31st, 2024. In August 2024, the preparation and administration of HD IV thiamine was changed from 500 mg IVPB administered over 30 minutes to 400 mg undiluted IV push over 2 minutes. The primary outcome was the average total cost comparing thiamine 500 mg IVPB versus 400 mg IV push. Secondary outcomes included cumulative dose administrations and AE.Results: A total of 731 patients met inclusion criteria with 339 (46%) receiving thiamine 500 mg IVPB infusion (2,493 doses) and 392 (54%) receiving thiamine 400 mg IV push (3,145 doses). The average total cost of HD thiamine therapy per patient was $91.12 for the 500 mg IVPB cohort and $59.05 for the 400 mg IV push cohort (p < 0.001). Additionally, the mean cumulative dose of thiamine administered was higher in the 500 mg IVPB cohort compared to the 400 mg IV push cohort (P = 0.002). Hypotension (0.5%) and burning sensation (1.0%) were only reported in the thiamine 400mg IV push group and were not statistically significant.Conclusions: The institutional change from thiamine 500mg IVPB to thiamine 400mg undiluted IV push resulted in significant cost savings with minimal risk for adverse events.","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 3","pages":"295-299"},"PeriodicalIF":0.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603117","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}

引用次数: 0

Stability of Naloxone in Normal Saline for Continuous Infusion. 纳洛酮在生理盐水中持续输注的稳定性。

International journal of pharmaceutical compounding Pub Date : 2026-05-01

Meghan Fletcher, Taylor Patek, Cody Wiley, Preeyaporn Sarangarm, Linda Felton

{"title":"Stability of Naloxone in Normal Saline for Continuous Infusion.","authors":"Meghan Fletcher, Taylor Patek, Cody Wiley, Preeyaporn Sarangarm, Linda Felton","doi":"","DOIUrl":"","url":null,"abstract":"Purpose: Administration of naloxone by continuous infusion for treatment of respiratory depression associated with long-acting opioids often necessitates extemporaneous preparations at drug concentrations that exceed the manufacturer's recommendation. The purpose of this study was to evaluate the stability of naloxone hydrochloride (N-HCl) in 0.9% sodium chloride at concentrations of 40, 80, and 200 mcg/mL.Methods: The appropriate volume was withdrawn from commercially available vials of N-HCl (400 mcg/mL) and injected into 100 mL 0.9% sodium chloride IV bags, which were then stored at room temperature under ambient laboratory lighting for at least four days. The 80 mcg/mL IV bags were also protected from light and evaluated over eight weeks. Samples were withdrawn over time and analyzed by high performance liquid chromatography to determine drug concentration.Results: The initial measured drug concentrations, expressed as a percentage of the theoretical values adjusted for overfill volume, ranged from 97.9% to 101.5% and remained above 97.5% of the initial values for four days. Measured drug concentrations in the 80 mcg/mL samples also remained high over the eight-week period, decreasing by about three percentage points. In addition, no significant difference in measured drug concentration was found between IV bags stored in amber sleeves and those exposed to ambient laboratory lighting.Conclusions: Extemporaneously compounded N-HCl in 0.9% normal saline IV bags at concentrations of up to 200 mcg/mL was stable over a four-day period when stored unprotected from ambient laboratory light at room temperature. Moreover, IV bags prepared at concentrations of 80 mcg/mL were also stable over an eight-week period. Ambient laboratory lighting did not adversely affect drug stability in the timeframe studied.","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 3","pages":"287-294"},"PeriodicalIF":0.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603188","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}

引用次数: 0

From Gaps to Maturity: How 503B Outsourcing Facilities Can Build a High Performing Supplier and Material Control Program. 从差距到成熟：503B外包设施如何建立一个高效的供应商和物料控制程序。

International journal of pharmaceutical compounding Pub Date : 2026-05-01

Michael L Magee

{"title":"From Gaps to Maturity: How 503B Outsourcing Facilities Can Build a High Performing Supplier and Material Control Program.","authors":"Michael L Magee","doi":"","DOIUrl":"","url":null,"abstract":"Supplier and material qualifications are one of the least visible, but most critical, elements of a 503B outsourcing facility's quality system. When it works well, it attracts little attention. When it breaks down, the consequences often appear in the areas FDA consistently evaluates production and process controls, sterility assurance, labeling controls, and patient safety. A quality maturity lens makes this topic practical. It helps leaders distinguish between having procedures on paper and having controls that function reliably in day to day operations. That perspective aligns with the principles reflected in FDA's Quality Management Maturity (QMM) initiative, which encourages manufacturers to move beyond baseline CGMP compliance toward systems that are proactive, resilient, and continuously improving. Although FDA's QMM program has been developed primarily in conventional pharmaceutical manufacturing, its core concepts, management commitment to quality, effective supply chain oversight, risk based decision making, and meaningful management review, translate directly to supplier and material control expectations relevant to 503B outsourcing facilities.1,2.","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 3","pages":"205-214"},"PeriodicalIF":0.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603119","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}

引用次数: 0

Formulation and In-Vitro Characterization of Gastroretentive Effervescent Floating Tablets of Meloxicam. 美洛昔康胃保留泡腾浮片的处方及体外表征。

International journal of pharmaceutical compounding Pub Date : 2026-03-01

Wisam Ghazi Sanad, Haidar Essam Jeleel, Qasim Allawi Bader

{"title":"Formulation and In-Vitro Characterization of Gastroretentive Effervescent Floating Tablets of Meloxicam.","authors":"Wisam Ghazi Sanad, Haidar Essam Jeleel, Qasim Allawi Bader","doi":"","DOIUrl":"","url":null,"abstract":"The present study was undertaken to design and evaluate gastro-retentive effervescent floating tablets of meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), with the aim of prolonging gastric residence time and achieving controlled drug release. Effervescent floating tablets were prepared using the wet granulation technique, employing polymers such as hydroxypropyl methylcellulose (HPMC), sodium alginate, Carbopol 934, and xanthan gum. Sodium bicarbonate and citric acid were incorporated as gas-generating agents to impart buoyancy. Among the investigated polymers, HPMC-based formulations demonstrated favorable floating behavior and sustained drug release characteristics. Dissolution studies indicated that the incorporation of Carbopol 934 with HPMC reduced meloxicam release from 98.1% to 92.9% over 12 h, while the combination of sodium alginate and xanthan gum further decreased drug release to 84.6% at the same time point. Evaluation of physicochemical properties, including hardness, friability, weight variation, buoyancy, and drug content, were within acceptable pharmacopeial limits. Overall, the developed gastro-retentive effervescent floating tablets of meloxicam demonstrated acceptable quality attributes and controlled drug-release performance, indicating their potential for improved gastric retention and therapeutic efficacy.","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 2","pages":"138-149"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963567","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}

引用次数: 0

Ethical and Regulatory Implications of Sourcing Drug X During an FDA-Reported Shortage: 503A vs. 503B Compounding Facilities. 在fda报告短缺期间采购药物X的伦理和监管影响：503A与503B复合设施。

International journal of pharmaceutical compounding Pub Date : 2026-03-01

Hayden R Asbill, W Mark Moore, Scott Asbill

引用次数: 0

Compounding and Stability Study of Dipyridamole and Clopidogrel Pediatric Oral Suspensions. 双嘧达莫、氯吡格雷小儿口服混悬液的配制及稳定性研究。

International journal of pharmaceutical compounding Pub Date : 2026-03-01

Lucile Dho, Said Ait Taleb, Lyna Kireche, Pascal Rathelot, Nicolas Primas, Christophe Jean, Patrice Vanelle, Arnaud Venet, Christophe Curti

引用次数: 0

Chemical and Microbiological Stability Supporting Extended BUDs in Pentravan® Based Transdermal Preparations. 化学和微生物稳定性支持扩展芽在潘曲万®透皮制剂。

International journal of pharmaceutical compounding Pub Date : 2026-03-01

Hudson Polonini, Carolina Schettino Kegele, Bruna Marianni

{"title":"Chemical and Microbiological Stability Supporting Extended BUDs in Pentravan® Based Transdermal Preparations.","authors":"Hudson Polonini, Carolina Schettino Kegele, Bruna Marianni","doi":"","DOIUrl":"","url":null,"abstract":"Transdermal drug delivery represents an important strategy in personalized medicine, offering advantages such as avoidance of first-pass metabolism, improved adherence, and sustained plasma concentrations. In compounding practice, the assignment of scientifically justified beyond-use dates (BUDs) requires robust evidence of both physicochemical stability and microbiological quality. This study evaluated the chemical and antimicrobial stability of compounded transdermal formulations containing dehydroepiandrosterone (DHEA, 0.1-10.0%), estradiol hemihydrate (0.01-2.0%), progesterone (1.0-20.0%), and propranolol hydrochloride (0.1-5.0%) prepared in Pentravan®. Stability-indicating UHPLC methods were developed and validated for each active pharmaceutical ingredient (API), and forced-degradation studies confirmed method specificity. Formulations were stored at room temperature and analyzed over 180 days, with acceptance criteria defined as 90-110% of labeled content. Antimicrobial effectiveness testing (AET) was performed according to USP <51> at initial and final stability time points. All analytical methods met validation criteria for specificity, linearity (r > 0.99), precision (CV < 5%), and accuracy (98-102%). Estradiol (0.01% and 2.0%), progesterone (1.0% and 20.0%), propranolol hydrochloride (0.1% and 5.0%), and DHEA 10.0% remained within specification for 180 days. DHEA 0.1% demonstrated significant potency loss at 180 days, supporting a BUD of 150 days. No relevant physical instability was observed, and all formulations complied with USP <51> antimicrobial effectiveness requirements throughout their assigned BUDs. These findings demonstrate that Pentravan® supports extended BUDs of up to 180 days for multiple clinically relevant transdermal APIs while maintaining chemical stability and preservative efficacy. Concentration-dependent stability was observed for DHEA, reinforcing the importance of formulation-specific evaluation when assigning BUDs in compounded preparations.","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 2","pages":"158-173"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963632","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}

引用次数: 0