International journal of pharmaceutical compounding最新文献

{"title":"Synthetic Peptides in Pharmacy Compounding: Analysis of PCAC Recommendations and Industry Safety Standards.","authors":"Jordan Willis, Nicole Vu","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Compounded peptides have quickly moved from a niche topic to a growing area of interest among patients and prescribers. These products are promoted for a wide range of uses, including tissue repair, inflammation, metabolic health, and healthy aging. This article examines the proposed uses of these peptides, the concerns raised during the review, and the practical implications for compounders.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 4","pages":"329-336"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989673","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":"Innovative Compounded Topical Powder for Post-Digital Amputation Care: A Clinical Case Study in Wound Healing.","authors":"Jacob Sweet, Mark A Gonzalez, Courtaney Davis, Fabiana Banov, Maria Carvalho","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Diabetes is a leading global cause of mortality and disability, with foot complications often resulting in amputation. Digital (toe) amputations are particularly common due to neuropathy, ischemia, and infection, and are frequently followed by delayed healing. This case describes a 66-year-old diabetic male who underwent multiple toe amputations on his right foot. Despite successful surgery, wound healing was slow. A compounded topical powder was prescribed, containing phenytoin, piperacillin, tazobactam, misoprostol, aloe vera, and beta glucan in a novel powder-to-hydrogel, film-forming topical compounding base (EctoSeal P2G™). Applied twice weekly for three months, the treatment led to complete wound closure without complications. The patient initially reported a poor quality of life, scoring 58 out of 68 on the Wound-QoL-17 questionnaire. By the end of treatment, both clinical progress and patient-reported outcomes indicated significant improvement. This case supports the key role of pharmacist-led, individualized wound therapies in post-amputation care.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 4","pages":"311-319"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989452","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 Evaluation of Compounded Multidrug Oral Liquids in a Dual-Vehicle Suspending System.","authors":"Carolina Schettino Kegele, Sarah Taylor, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Extemporaneously compounded oral liquids are essential for patients unable to swallow solid dosage forms, although ensuring stability in aqueous systems remains challenging. This study evaluated the chemical, physical, and microbiological stability of formulations containing topiramate, omeprazole, gabapentin, ondansetron, and levofloxacin prepared in Flavor Sweet™ SF and Flavor Plus™, also known as Syra Sweet™ SF and Syra Plus™. Stability was assessed over 90 days at room temperature and under refrigeration using validated UHPLC methods, along with physical and microbiological analyses. Gabapentin, ondansetron, omeprazole, and topiramate remained stable for 90 days under both conditions, while levofloxacin was stable for 60 days at room temperature and 90 days refrigerated. All formulations showed consistent pH and acceptable microbiological quality, although precipitation in some samples led to discontinuation of analysis. These results support the suitability of the vehicle system and highlight the importance of formulation parameters in stability and beyond-use dating.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 4","pages":"379-391"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989741","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":"Development and Chemical Stability Assessment of a Methyl-β-Cyclodextrin-Containing Dextromethorphan/ Quinidine Oral Solution for Extemporaneous Compounding.","authors":"Cedric Wernli, Uli Loesch","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Pseudobulbar affect is a distressing condition frequently observed in patients with amyotrophic lateral sclerosis (ALS), for which a fixed-dose combination of dextromethorphan and quinidine is approved in the United States. In Europe, no commercial product is available, and compounded capsules or suspensions are used; however, capsules may be unsuitable for patients with dysphagia, and suspensions require shaking before administration. The aim of this study was to develop simple fully water-soluble formulation of dextromethorphan hydrobromide and quinidine sulfate using methyl-ß-cyclodextrin as a solubilizing agent and to evaluate its stability under different storage conditions, enabling pharmacies to compound the preparation without complex infrastructure. Preliminary qualitative solubility experiments showed that the dextromethorphan hydrobromide/ quinidine sulfate powder mixture did not dissolve in water without methyl-ß-cyclodextrin. Addition of methyl-ß-cyclodextrin improved dissolution; however, the initial preparation targeting 20 mg/mL dextromethorphan hydrobromide and 10 mg/mL quinidine sulfate in a final volume of 100 mL remained incompletely dissolved. Increasing the final volume to 250 mL yielded a clear formulation containing nominal concentrations of 8.4 mg/mL dextromethorphan hydrobromide and 4.2 mg/mL quinidine sulfate. Three independently prepared batches were stored in amber PET bottles providing light protection and fitted with child-resistant closure at 2-8°C, 15-25°C, and 40°C and analyzed by HPLC for four weeks. HPLC assay values remained within 10% of the corresponding baseline values at each storage condition, and no visible precipitation was observed. The results support the physical clarity and chemical consistency of the tested methyl-ß-cyclodextrin- containing formulation over four weeks under the evaluated storage conditions. Microbiological stability, preservative effectiveness, formal method validation in the author's laboratory, and the extent of cyclodextrin inclusion complexation were not assessed. This formulation may serve as a basis for further pharmaceutical, microbiological, and clinical evaluation of an extemporaneously compounded oral liquid.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 4","pages":"393-399"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989322","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":"Metamorphosis in Drying Techniques for Biopharmaceuticals.","authors":"Aditya Vikas Mane, Karina Arora, Nitya Srivastava, Prince Kumar, Gurvinder Singh, Ankit Kumar Yadav, Rajesh Kumar","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Biopharmaceutical products such as proteins, peptides, and nucleic acid-based therapeutics exhibit limited physicochemical stability in aqueous formulations. The process of developing and producing these bioproducts is often difficult and requires careful attention, particularly when it comes to drying for long-term storage and distribution of the final product. Conventional drying techniques like freeze-drying and spray drying have been widely used to enhance product stability, but are limited to their time and high-energy consumption. Over the years, significant technological advances in drying processes have emerged to address these limitations and improve process efficiency. This review discusses the principles and applications of both conventional and emerging drying techniques used in biopharmaceutical manufacturing, with particular emphasis on advanced approaches such as spin freeze drying, spray freeze drying, microwave-assisted drying, active freeze drying, and continuous freeze drying of suspended vials. The advantages, limitations, and potential of these technologies in improving biopharmaceutical formulations, their stability, processing efficiency, and industrial scalability are critically examined.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 4","pages":"345-357"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989646","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":"Novel Compounding Approach to Floating Alginate Microbeads for Glipizide: Influence of Polymer Matrix on Swelling, Buoyancy, and Drug Release Kinetics.","authors":"Shiv Kumar Srivastava, Antesh Kumar Jha, Ritesh Kumar Srivastav, Arun Kumar Tiwari, Mahesh Prasad","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>A BCS class II medication, glipizide has a short half-life and limited solubility; frequent dosage is necessary for efficient glycemic management. A compounding-based gastroretentive drug delivery method employing floating alginate microbeads for prolonged release was created to circumvent these limitations.</p><p><strong>Methods: </strong>Sodium alginate was used in the ionic gelation process to create floating microbeads, which were then refined by adjusting the quantities of polymers and crosslinkers. The formulations were evaluated for buoyancy, swelling behavior, entrapment efficacy, particle size, and in vitro drug release. Release data were fitted into kinetic models (Zero-order, First-order, Higuchi, and Korsmeyer-Peppas) in order to determine the mechanism of drug release.</p><p><strong>Results: </strong>Every formulation demonstrated acceptable floating capacity and physicochemical characteristics. With great entrapment efficiency, outstanding buoyancy for more than 12 hours, and a total drug release of 98.86% at 12 hours, formulation F9 outperformed the others. According to kinetic modeling, F9 best matched the Korsmeyer-Peppas model (R2 = 0.998, n = 0.71), suggesting that both diffusion and polymer relaxation/erosion are responsible for anomalous (non-Fickian) release.</p><p><strong>Conclusion: </strong>According to the study, floating alginate microbeads made using a compounding-based method provide a potentially effective gastroretentive substrate for Glipizide's prolonged release. This approach may improve patient compliance, extend the therapeutic effect, and increase bioavailability. To support the in vitro results, more in vivo research is advised.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 4","pages":"358-370"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989749","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 E-Tongue Evaluation of Taste-Masked Chewable Ferrous Ascorbate Tablets Using Design of Experiment.","authors":"Kumaravelrajan Rajagopal, Satyanarayanan Sekar, Kannan Muthusamy, Clement Atlee William, Lakshmi Priya Arul, Shyam Sundar Subramanian, Tharani Thanigaivel, Suba Venkatesan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This study aims to develop and optimize taste-masked chewable iron tablets using Hydroxypropyl beta-cyclodextrin (HPßCD) and E-Tongue technology to improve patient compliance. A 2-level factorial design was employed to evaluate the effects of HPßCD, isomaltose, and Pearlitol® on the formulation. By using design of experiment the effect of each factor individually on the response can be predicted. There are 8 runs in this design the response for each 8 formulations is predicted individually by using design expert software. The composition of the tablet formulation was optimized using full factorial 23design, which is desirable for response surface methodology to optimize complex formulations. The results demonstrated favorable flow properties, with consistent bulk and tapped densities, and excellent mechanical strength, particularly for F8. In-vitro dissolution studies revealed a high cumulative drug release (93.75%) for F8. E-Tongue analysis indicated that F8 exhibited superior taste-masking efficiency, with the lowest bitterness score. The optimised chewable tablet evaluated for bitter score and hardness. According to point prediction mean predicted was found to be 4.1 for bitter score and observed mean was 4 and for hardness the predicted mean was 13kg/density and observed mean was 14 kg/density. Therefore, the optimised formulation F9 was Drug:CD (1:5), Sweetening agent (11.25mg) and Pearlitol (90 mg) Additionally, chewability was influenced by tablet hardness, with F8 showing the highest chewability difficulty index. The optimized formulation (F8) provides a balanced combination of taste masking, drug release, and mechanical strength, enhancing patient adherence.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 4","pages":"371-378"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989446","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":"Letter to the Editor - Regarding Blotske et al: \"Evaluating the Utilization and Cost Analysis of High-dose Thiamine when Compounded or Administered via Intravenous Push at an Academic Medical Center\".","authors":"Robert S Hoffman","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 4","pages":"309-310"},"PeriodicalIF":0.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148989643","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":"Development and Optimization of Antioxidant Poly Herbal Peel-off Mask using Doe Based Approach.","authors":"Devika Ramakrishnan, Jithesh Mr, Jisna Joy, Gifty M Jojo, Fthima Samah Abbas","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Antioxidants protect the skin from free radicals, which are associated with signs of aging, pigmentation, and loss of elasticity. Combining antioxidants in cosmetic formulations may provide broader antioxidant potential. This study focuses on the formulation and optimization of a polyherbal antioxidant peel-off mask using extracts of Ocimum sanctum (Tulsi), Moringa oleifera (Moringa), and Trigonella foenum-graecum (Fenugreek), which are reported to possess antioxidant and skin-beneficial properties.</p><p><strong>Methodology: </strong>The formulation and optimization of the polyherbal peel-off mask were carried out using Central Composite Design (CCD). Polyvinyl alcohol (PVA) and carbomer 940 served as film-forming agents, while triethanolamine was used to adjust viscosity. The optimized formulation was evaluated for physicochemical characteristics, in vitro antioxidant activity, and irritation potential using the HET-CAM assay.</p><p><strong>Results: </strong>The optimized formulation exhibited a drying time of 25.3 minutes and an applicability score of 18.82. Physicochemical evaluation showed acceptable homogeneity, smooth texture, and pH suitable for topical application. In vitro antioxidant assays demonstrated a lower IC50 value for the polyherbal mask compared to the standard vitamin C formulation, indicating notable antioxidant activity. Furthermore, the CAM (chorio-allantoic membrane) irritation test showed no observable signs of irritation such as hemorrhage, lysis, or coagulation under the study conditions.</p><p><strong>Conclusion: </strong>This study successfully formulated and optimized a polyherbal peel-off mask with promising in vitro antioxidant activity and acceptable physicochemical characteristics. The use of Central Composite Design (CCD) enabled systematic optimization of the formulation variables. The findings suggest the potential applicability of the developed herbal formulation for cosmetic skincare applications; however, further stability studies and in vivo safety and efficacy evaluations are required.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 3","pages":"237-252"},"PeriodicalIF":0.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603163","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 a 100 mg/mL Sodium Benzoate Solution in Water for Parenteral Use.","authors":"Isabelle St-Jean, Mihaela Friciu, Lola Bonnemain, Annie Lavoie, Jean-Marc Forest, Grégoire LeClair, V Gaëlle Roullin","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Context: </strong>Sodium benzoate is mainly used as a preservative in food and pharmaceuticals and as a treatment for hyperammonemia in urea-cycle disorders. It is typically diluted in 5 or 10% dextrose solutions for intravenous administration to patients. While the stability of oral and injectable sodium benzoate formulations has been studied, there is limited research on its stability as an injectable solution under International Council for Harmonisation (ICH) conditions.</p><p><strong>Aim: </strong>This study evaluates the stability of a sodium benzoate injectable formulation in sterile water (100 mg/mL).</p><p><strong>Methods: </strong>A 100 mg/mL sodium benzoate solution was prepared in sterile water. A highperformance liquid chromatography method with UV detection (HPLC-UV) was developed for dosage measurement. The solution was stored in sterile glass bottles at room temperature (25°C) and under refrigeration (5°C). The effects of plastic and rubber screw caps on stability were also assessed. Stability was monitored over 230 days using validated HPLC-UV methods, and microbiological assays were performed to ensure sterility per USP <797> and USP <81> standards, as required by the \"Ordre des pharmaciens du Québec.\"</p><p><strong>Results: </strong>Sodium benzoate preparations in 10-mL horizontal and inverted glass bottles remained stable for at least 230 days at both storage conditions.</p><p><strong>Conclusions: </strong>Sodium benzoate injectable preparations can be stored safely for 230 days at both room temperature and under refrigeration, maintaining efficacy and safety for intravenous patient administration. However, microbiological and endotoxin testing are necessary for each batch to ensure continued safety and effectiveness, according with the Quebec sterile production standard OPQ 2014.01.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 3","pages":"219-228"},"PeriodicalIF":0.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148603202","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}