International journal of pharmaceutical compounding最新文献

{"title":"Bringing Risk-Based Auditing to 503A Pharmacy Accreditation.","authors":"L Rad Dillon, Michael Magee","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Compounding pharmacies operate in a complex regulatory environment where not all deficiencies carry equal consequences. Traditional checklist-based inspections are effective at verifying compliance with published standards, but they often fail to distinguish minor documentation lapses from conditions that pose significant risk to patients, staff, or the viability of the pharmacy itself. Risk-based auditing offers a more targeted, defensible approach, one that aligns inspection effort with the severity and likelihood of harm. This article explores how risk-based auditing principles can be applied to 503A pharmacy accreditation, and how hybrid models can deliver both comprehensive oversight and meaningful risk reduction.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 2","pages":"94-103"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963558","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":"Nanoemulsion Reformulation of Nitrosylcobalamin (NO-Cbl) Enhances Solubility, Stability, and Anti-Tumor Potency.","authors":"Joseph A Bauer, Annette M Sysel, Michael J Dunphy","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Nitrosylcobalamin (NO-Cbl), a vitamin B12-based nitric oxide donor, has demonstrated selective antitumor activity. However, its translational development has been limited by formulation challenges, including restricted solution concentration and concerns regarding stability. To address these limitations, we developed a nanoemulsion reformulation of NO-Cbl (NanoE-NO-Cbl).</p><p><strong>Materials and methods: </strong>NO-Cbl was reformulated into a nanoemulsion composed of soy lecithin, soybean oil, sucrose, and water using a high-shear Microfluidizer® processor. HPLC analysis and physicochemical characterization were used to assess NanoE-NO-Cbl for identity and stability across multiple storage conditions. Quantitative stability was evaluated by assay, chromatographic purity, pH, and droplet-size measurements. Antitumor activity was assessed in A375 melanoma cells using the sulforhodamine B (SRB) proliferation assay.</p><p><strong>Results: </strong>Reformulation of NO-Cbl into a nanoemulsion increased the achievable formulation concentration relative to buffer-based preparations and enhanced potency approximately five-fold in A375 melanoma cells in vitro. NanoE-NO-Cbl demonstrated improved formulation stability under frozen and refrigerated storage conditions.</p><p><strong>Conclusion: </strong>Reformulation of NO-Cbl into a nanoemulsion improves formulation concentration, stability, and antitumor potency, providing a strong rationale for further preclinical development.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 2","pages":"174-183"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963581","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 Benzocaine, Lidocaine, and Tetracaine in VersaPro™ Cream Base.","authors":"Mihaela Friciu, Ouafa Benzina, Kathryn Hunt, Erica Cull, Grégoire LeClair","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Compounded Benzocaine (20%), Lidocaine (6%), and Tetracaine (4%) in VersaPro™ Cream Base was studied to evaluate the chemical, physical, and microbial stability over a 180-day period. Preparations were stored in ambient conditions in tightly closed, light-resistant, metered-dose plastic containers. An HPLC assay was developed and validated to assess chemical stability, while physical stability was assessed by observing organoleptic characteristics and measuring pH levels. Antimicrobial effectiveness testing was conducted according to USP <51> at the final stability time point. The results indicate that combined Benzocaine (20%), Lidocaine (6%), and Tetracaine (4%) compounded in VersaPro™ Cream Base was stable for the duration of the study and may be assigned an extended beyond-use-date of 180 days under the examined conditions.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 2","pages":"150-156"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963618","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":"Turning Employees into Compliance Assets: Managing and Preventing Claims Based on Failed OBRA '90 and USP <800> Compliance.","authors":"Michael R Alexander, Jesse Fishman, Matthew D Earl, Brad Howard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A strong compliance program requires attention, engagement, and active monitoring of pharmacists and pharmacy professionals. Done well, compliance is routine, consistent, even mundane. Yet these very characteristics can create a culture of complacency that pharmacies must actively guard against. This potential risk is only compounded by the wide range of regulatory and contractual rules that bind the practice of pharmacy. Compliance involves tracking everything from state and federal laws-each state's pharmacy act, the Federal Controlled Substances Act, Stark and anti-kickback statute requirements, to name a few-to USP and accreditation standards, and even to government and commercial payor requirements and restrictions. The sheer scope and complexity of regulatory demands can be overwhelming. While pharmacies are watchful for liability warning signs like false claims, kickbacks, and controlled substance risks, inadequate attention to other regulatory requirements can also result in substantial liability to the pharmacy. This article examines two compliance areas that present unique challenges in compounding: USP <800> and OBRA '90. It addresses the potential liabilities and risks of noncompliance associated with each; how pharmacies can effectively leverage employees as compliance assets; and what to do if an employee blows the whistle about alleged violations of USP <800> or OBRA '90.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 2","pages":"104-118"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963592","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":"Case Series of Veterinary Cancer Patients Treated with Oral Low-Dose Naltrexone.","authors":"Meagan A Garza, Steve Hoffart, Melissa Parsons-Doherty, Deborah H Clark, Fabiana Banov, Maria Carvalho","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A veterinary referral center specializing in veterinary oncology collaborated with a local compounding pharmacy to evaluate the effects of adding low-dose naltrexone (LDN) to the palliative care of dogs undergoing treatment for various cancers. Seven male neutered dogs were initially enrolled, each prescribed naltrexone 2 mg or 4.5 mg capsules (LoxOral), depending on body weight. Dosing began once daily for 30 days, then increased to twice daily for the remainder of the three-month study. Health-related quality of life (HRQoL) was assessed at baseline and every 9-10 days using a structured, cancer-specific veterinary questionnaire. Four dogs were evaluable, representing diagnoses of hepatocellular carcinoma, T-cell lymphoma, osteosarcoma, and multilobular osteochondrosarcoma. Improvements were observed in multiple domains, including happiness, mental status, pain control, appetite, hydration, and mobility. Owners consistently reported a maintained or enhanced quality of life. The treatment was well tolerated, with no adverse events reported. These results suggest that oral compounded LDN may be a valuable palliative care option in veterinary oncology, particularly when incorporated upon diagnosis to help preserve quality of life throughout treatment.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 1","pages":"12-21"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443617","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":"Equine Protozoal Myeloencephalitis: An Ancient Parasite Meets Modern Compounding.","authors":"Michelle Bethel","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>EPM remains particularly rampant in racing populations due to transport stress, young age, and congregate housing conditions. For compounding pharmacists, understanding that we're managing chronic parasite suppression - not achieving cure - fundamentally changes our approach to formulation strategy, stability assessment, and client counseling. The two formulations presented separately represent years of refinement, demonstrating compounding's essential role when commercial products fall short.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 1","pages":"23-25"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443649","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":"Pilocarpine in the Management of Allergic Rhinosinusitis.","authors":"Lydia M Theodoropoulou, Niamh A Cullen","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>This retrospective study addresses the question of inadequate cholinergic output in Allergic Rhinosinusitis (ARS) and the feasibility of its treatment with cholinergics. Pilocarpine, a muscarinic-receptor agonist, was administered to patients with refractory obstructive sino-nasal symptoms to improve secretion and clearance.</p><p><strong>Methods: </strong>The 22-item sino-nasal outcome test (SNOT-22) was used to identify patients with recalcitrant obstructive symptoms. Patients with SNOT-22 scores greater than 16 were treated with pilocarpine 5 mg three times a day (tid), twice a day (bid), or once a day (qd); changes of their scores were compared to those of patients who were not treated with pilocarpine. SNOT-22 was administered on presentation and at follow-up at 3 and 6 months. At 6 months of treatment, pilocarpine was discontinued. Six to nine months post-discontinuation the SNOT-22 was re-administered to assess sustainability.</p><p><strong>Results: </strong>Severe obstructive-type ARS was identified in 48 patients over a four-year period. Nineteen patients received pilocarpine; two discontinued treatment due to side effects; eight required dosing adjustment. SNOT-22 scores were lower in the pilocarpine-treated group at 6 months of treatment and at 6-9 months after discontinuation (p < 0.05 for both). Longitudinal SNOT-22 scores improved in the pilocarpine tid-treated sub-group at 6 months of treatment and at 6-9 months after discontinuation (p < 0.05 and < 0.01 respectively). Significant SNOT-22 decline was also reached at p < 0.1 for subjects on pilocarpine qd, but was not sustained upon discontinuation.</p><p><strong>Conclusions: </strong>Pilocarpine can be useful in the treatment of refractory sino-nasal blockage. Adverse effects are frequent at 5 mg tid, but lower dosing can be effective.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 1","pages":"32-41"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443620","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":"Comparing the Effect of Drug, Sodium Carboxymethyl Cellulose and Other Excipients on Shape, Size and Drug Release from the Matrices.","authors":"Hassan Alhmoud, Yazan Akkam, Omar Alhmoud","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Purpose: </strong>Sodium Carboxymethyl Cellulose (NaCMC) is frequently employed in pharmaceutical formulation. Nevertheless, there are potential interactions between NaCMC and specific drugs, which may have an impact on the stability or bioavailability of those drugs.The purpose is to study the effect of drugs with different charges, anionic Sodium Carboxymethyl Cellulose (NaCMC), excipients, and other parameters on shape, size, and drug release from controlled release matrices of three different drugs and the kinetics of drug release were investigated.</p><p><strong>Methods: </strong>Three models of drug matrices (Flurbiprofen, naproxen sodium, and propranolol hydrochloride) were prepared using the direct compression technique with different ratios of sodium carboxymethyl cellulose, other excipients, and surfactants of various solubility and charges. These were used to compare drug release from the matrices in simulated intestinal fluid pH = 7.4 and simulated gastric fluid pH = 1.2. The size and shape changes of the matrices were investigated when these tablets were placed in simulated gastric fluid and simulated intestinal fluid. The mechanisms of drug release were analyzed using different models and equations.</p><p><strong>Results: </strong>Sodium Carboxymethyl Cellulose (NaCMC) had the most significant effect on controlling drug release, swelling rate, size, and shapes of the matrices of the three drugs, regardless of their solubility. The pH of the dissolution medium, surfactants and other excipients, charge, and solubility of the drug also influenced drug release, tablet size, and shape of the different formulations.</p><p><strong>Conclusions: </strong>The swelling rate of the different matrices was constrained only by NaCMC. The ratio of anionic NaCMC primarily controlled the release rate of drugs. The shape and size of the matrices, according to the solubility and charge of these drugs. Other excipients, such as surfactants, lactose, and magnesium stearate, affected the release rate of the drugs, shape and size of the matrices but did not influence their swelling rate.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 1","pages":"64-77"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443613","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":"Design and Characterization of Doxepin In-situ Nasal Gel Using Pectin as a Bio-compatible Matrix.","authors":"Antesh Kumar Jha, Shiv Kumar Srivastava, Mahesh Prasad","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The goal of the current study is to formulate a Doxepin hydrochloride ion triggered trans-nasal gel. The developed formulations were evaluated for gel strength, gelation time, viscosity, mucoadhesion strength, ex-vivo drug permeability drug content, and stability. According to the findings, mucoadhesive strength and viscosity increased as pectin and hydroxypropyl methylcellulose (HPMC) K4M concentrations increased, whereas gelation time and the percentage of drug recovery decreased. With 3.5% pectin and 1.5% HPMC, the improved formulation C2F2 demonstrated the greatest drug release of 97.96% via sheep nasal mucosa. The stability study over a period of three months showed no change in viscosity, pH and drug content. The discovered ion-triggered intra nasal formulations shows enhanced locomotor activity and mobility in mice, when used to treat depression.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 1","pages":"42-56"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443622","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":"Between Necessity and Compliance: Understanding FDA's GFI #256 for Animal Drug Compounding.","authors":"Jordan T Vogel, Brad Howard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The practice of compounding animal drugs using bulk drug substances presents a challenging intersection of veterinary need and federal regulatory compliance. Governed by the Federal Food, Drug, and Cosmetic Act (\"FDCA\"), this area of animal healthcare has long operated in a legal gray zone, with the FDA traditionally exercising discretion in its enforcement. To bring clarity to this nuanced issue, the FDA issued Guidance for Industry #256 (\"GFI #256\"), which outlines the specific circumstances under which the agency will decline to take enforcement action against compounders of animal drugs using bulk drug substances. This article explores the practical implications of GFI #256 for veterinarians and compounders, focusing on three critical requirements that must be met when compounding bulk drug substances for non-food-producing animals under a patient-specific prescription. stakeholders can better navigate the complex regulatory landscape and ensure their practices align with FDA expectations.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"30 1","pages":"6-11"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147443579","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}