International journal of pharmaceutical compounding最新文献

{"title":"Physiochemical and Microbiological Stability of Azathioprine Suspensions in PCCA Base, SuspendIt.","authors":"Yahoda V Pramar,&nbsp;Tarun K Mandal,&nbsp;Levon A Bostanian,&nbsp;Cyndy Kader,&nbsp;Tommy C Morris,&nbsp;Richard A Graves","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Azathioprine is used to treat the symptoms of rheumatoid arthritis and for the prevention of transplant rejection. A review of the therapeutic uses of Azathioprine reveals the need for flexibility in dosing. This flexibility is readily achieved using an oral liquid dosage form. However, no commercial liquid dosage form of Azathioprine currently exists. Azathioprine is commercially available only as a 50-mg tablet. An extemporaneously compounded suspension from pure drug powder would provide a flexible, customizable option to meet unique patient needs with convenient and accurate dosing options. The purpose of this study was to determine the physicochemical and microbiological stability of extemporaneously compounded Azathioprine suspensions in the PCCA Base, SuspendIt. This base is a sugar-free, paraben free, dye-free, and gluten-free thixotropic vehicle containing a natural sweetener obtained from the monk fruit. The study design included two Azathioprine concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. A robust stability-indicating high-performance liquid chromatographic assay for the determination of the chemical stability of Azathioprine in PCCA SuspendIt was developed and validated. Suspensions of Azathioprine were prepared in PCCA SuspendIt at 10-mg/mL and 50-mg/mL concentrations, selected to represent a range within which the drug is commonly dosed. Samples were stored in amber plastic prescription bottles at two temperature conditions (5°C and 25°C). Samples were assayed initially, and on the following time points (days): 7, 14, 28, 49, 63, 90, 119, and 182. Physical data such as pH, viscosity, and appearance were also noted. Microbiological stability was tested. All measurements were obtained in triplicate. A stable extemporaneous product is defined as one that retains at least 90% of the initial drug concentration throughout the sampling period and is protected against microbial growth. The study showed that Azathioprine concentrations did not go below 96.8% of the label claim (initial drug concentration) at both temperatures studied. No microbial growth was observed. The pH values remained constant. The viscosity of the suspensions allowed easy re-dispersal of the drug particles upon shaking. This study demonstrates that Azathioprine is physically, chemically, and microbiologically stable in PCCA SuspendIt for 182 days in the refrigerator and at room temperature, thus providing a viable, compounded alternative for Azathioprine in a liquid dosage form, with an extended beyond-use date to meet patient needs.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10028499","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":"Sterile Basics of Compounding: Intravenous Admixture Compounding, Part 3: Preparation Procedures.","authors":"Loyd V Allen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Intravenous admixture compounding is common practice in most hospitals throughout the world, regardless of the country. Compounding intravenous medications medications involves risk as there is a high potential for error due to their complexity in compounding, and working in an aseptic environment itself poses issues for the compounder. Part 1 of this series presented an introduction and an overview of the series; part 2 presented parenteral vehicle considerations and examples; and part 3 discusses preparation procedures as well as discussions on standardization (both formulas and procedures), competency, compliance issues, issues with using commercial product additives, and look-alike drugs.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10028505","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: Our Lives Are Shaped by the Decisions We Make!","authors":"Loyd V Allen","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10025814","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":"Topical Vehicles: A Dermatologist's Perspective.","authors":"Stephanie Adame,&nbsp;Michael E Collins,&nbsp;Abraham M Korman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Topical treatment is mainstay for a variety of dermatologic conditions. There are several different types of topical vehicles, and choosing the most appropriate one is an essential part of treatment. Selection can vary depending on factors such as patient preference and anatomical location. Each topical vehicle has unique advantages and disadvantages that are important to consider. This article reviews some of the most common topical vehicles used in dermatology.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10025817","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 In Vitro Evaluation of a Ramipril Entrapped in a Microsponge-based Drug-delivery System.","authors":"Hassanien Sagban Taghi,&nbsp;Mustafa R Abdulbaqi,&nbsp;Laith Hamza Samein,&nbsp;Maha H Philip Rahmani","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Microsponges are porous cross-linked polymers, which have the ability to load a wide range of pharmaceutical active ingredients. They are used topically for long-term treatment applications in addition to the oral route of administration. They are characterized by the efficient distribution of active ingredients, which are loaded at a low quantity to release the drug over longer periods of time by altering the release characteristics. The objective of this study was to develop a novel drug-delivery system that included ramipril microsponges. Ramipril is an antihypertensive drug used in the treatment of elevated blood pressure. It has about 28% oral bioavailability and is eliminated through the kidneys. When administered in an instant dosage form, this medicine produces several side effects, including postural hypotension, hyperkalemia, and angioedema. Included in this study were six distinct formulas of microsponges containing ramipril and Eudragit L 100 at varied ratios that were prepared by using the Quasi-emulsion solvent diffusion technique to avoid side effects. The particle size and physical characteristics of these formulations were investigated. The effects of the polymer/drug ratio on the physical features of a microsponge's physical and compatibility study was performed by using the Fourier transform infrared spectroscopy, differential scanning calorimetry, loading efficiency, surface morphology, and particle sizes. In addition, an in vitro drug-release profile was conducted. The physical characterization showed that the loading efficiency and production yield were both improved for microsponge formulation F1. In vitro dissolution studies were performed on all formulations, and the findings were analyzed kinetically, revealing that the ramipril release rate was altered in all formulations. This study offers a new medication delivery method based on microsponge technology.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10028501","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 Report in Equine: Highlighting the Benefits of Medisca CopaSil in Burn Scar Management.","authors":"Jason Heuerman,&nbsp;Halema Haiub,&nbsp;Erica Cull,&nbsp;Rodrigo Lupatini,&nbsp;Brandon Shrum,&nbsp;Raman Sidhu","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In this case report, we highlight the benefits of Medisca CopaSil application for scar healing in a horse having sustained second-degree burn injuries covering most of its back. The application of CopaSil started three months after sustaining the burn injury when silver sulfadiazine topical cream treatment showed no significant improvement. CopaSil is formulated with ingredients that may help in reducing inflammation and accelerate healing by modulating the immune response. After using CopaSil for six months, the horse's back was healed, and the hair began to regrow. The complete healing was achieved within six months, and full recovery was reported and confirmed by the horse's owner and pharmacist. This case report highlights the outcomes and benefits of CopaSil in improving the appearance of scars.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10028497","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":"Compounding for the Treatment of COVID-19 and Long COVID, Part 4: The Legacy of Chronic COVID.","authors":"Mike Riepl,&nbsp;Joe Kaiser","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>People infected by severe acute respiratory coronavirus 2 (SARS-CoV-2) risk the development of not only acute coronavirus- disease-2019 (COVID-19) - the signs and symptoms of which range from none to severe illness that requires intensive treatment - but also long COVID (i.e., chronic COVID), a cyclical, progressive, multiphasic illness characterized by myriad debilitating conditions that persist long term. In some patients, those sequelae result in psychiatric disorders that can lead to suicide or other forms of self-harm, incidences of which have increased exponentially since before the COVID pandemic. It has been suggested that long COVID develops in an estimated 10% to 35% of people diagnosed as having COVID-19. Because the success of therapy for either form of COVID can be complicated by each patient's pharmacogenomic profile, personal treatment preferences, medical needs, and/or dosing requirements, we have found that in some people so afflicted, manufactured medications are ineffective or intolerable, and that for those individuals, a customized compound often provides relief and promotes recovery. The primary focus of this article is long COVID. The pathogenesis of that disease is reviewed, therapies for the signs and symptoms it engenders are examined, and 2 compounded formulations effective in treating both acute and chronic COVID-19 are presented.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10028502","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 of Omeprazole Extemporaneous Oral Solution in Chopin Base.","authors":"Antonio Spennacchio,&nbsp;Angela Assunta Lopedota,&nbsp;Flavia Maria la Forgia,&nbsp;Sergio Fontana,&nbsp;Nunzio Denora,&nbsp;Antonio Lopalco","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Omeprazole is the progenitor of proton pump inhibitors. It is used for the treatment of ulcer and gastroesophageal reflux in dosages ranging from 10 mg/day to 40 mg/day, calibrated according to the patient's age and body weight. In this study, the authors provide a report on the preparation of an extemporaneous liquid formulation of omeprazole using fast oral solution Chopin a hydroxypropyl-?-cyclodextrin liquid base (pH 8 to 9) that is able to solubilize the drug. A solubility study of the drug in the liquid vehicle and a physical-chemical stability study of the 1-mg/mL formulation at 4°C and 25°C were performed. Analyses were carried out by using a high-pressure liquid chromatographic analytical method. Results showed that the intrinsic solubility of the drug in Chopin base was 5.33 mg/mL ± 0.23 mg/mL at 25°C and that omeprazole was chemically stable when the formulation was stored at 4°C over a period of 3 months, while its shelf life at 25°C was only 9 days. This study has demonstrated that the resulting liquid formulation is suitable for all patients, in particular children or adults who are unable to take other pharmaceutical dosage forms, which overcomes the limitations of the medicines currently available on the market.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9564877","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":"Compounding for the Treatment of COVID-19 and Long COVID, Part 3: The Role of Toll-like Receptors in SARS-CoV-2 Infection and COVID Development.","authors":"Mike Riepl,&nbsp;Joe Kaiser","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Toll-like receptors, which are type I transmembrane proteins and pattern recognition receptors found on cell surfaces and in intracellular membranes, serve as central mediators of both initial innate-immune responses and secondary adaptive/acquired-immune responses. Toll-like receptor 4, the activation of which leads to the synthesis of proinflammatory cytokines and chemokines, has been shown to have a vital role in the innate immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In our practice of pharmaceutical compounding, we noted that some individuals with coronavirus disease- 2019 (COVID-19) or long COVID achieved limited or no benefit from commercially manufactured treatments designed to alleviate symptoms and enable recovery. We suggest that in such cases, a compounded formulation, which can be easily customized to provide that support, may be of benefit. This article provides a brief review of the ways in which toll-like receptors in general, and toll-like receptor 4 in particular, affect the development and progression of SARS-CoV-2 infection and COVID-19, especially with respect to the human respiratory and central nervous systems and people rendered vulnerable by a comorbid condition (diabetes, obesity) or age. Instructions for compounding 2 customized preparations useful in the treatment of COVID-19 and long COVID are also provided.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9564878","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":"An Alternative Approach to Tablet Splitting and Grinding for Medication Administration.","authors":"Rajneesh Taneja,&nbsp;Joseph Scarim,&nbsp;Poonam G Pande,&nbsp;Anthony Scarim,&nbsp;Milap C Nahata,&nbsp;Rita K Jew,&nbsp;Koteswara Rao Inabathina","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Tablet formulations fail to meet the needs of patients unable to swallow tablets such as pediatric, elderly, and patients that must receive medications via feeding tubes. Our objective was to develop and test a new, simple device (XTEMP-R) and the methodology for converting tablets into a homogeneous suspension for medication administration. We developed a new device comprised of a flexible receptacle, a tight-fitting cap, and a suction cup bottom to convert tablets into liquid preparations. Tuberculosis treatment drugs, TBAJ-876 and TBI-223, were dispersed within the device utilizing water and commonly available suspending vehicles. We investigated the effectiveness of the XTEMP-R device in dispersing tablets. This was accomplished by visual observations, determining the fineness of dispersion, and measuring the total drug recovery from the dispersions in XTEMP-R. We investigated the accuracy and reproducibility of delivering aliquots from these suspensions by determining the dose reproducibility upon suspension and upon redispersion after 24 hours. The effectiveness of the device was also evaluated using commercially available tablets of acetaminophen, amlodipine, glimepiride, metformin, and valsartan. The suspensions were visually uniform without any large particles. The suspensions passed through a #18 sieve confirming that the particles were less than 1000 µm. The average total dose recovery of three suspensions each was determined to be 101.3% and 99.2% for TBI-223 and TBAJ-876, respectively. Reproducibility from aliquots of 2 mL each was 98.9% to 99.7% for three replicates of TBI-223 suspensions, and 102.6% to 103.2% for TBAJ-876 suspensions. Aliquots tested after 24 hours confirmed uniform redispersibility. We have demonstrated that XTEMP-R can be utilized to prepare homogeneous suspensions conveniently and efficiently in less than 10 minutes without any drug loss. Aliquots for partial dose delivery can be withdrawn accurately. These findings demonstrate that XTEMP-R can be used to accurately deliver doses of suspensions for patients who cannot swallow tablets.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9573701","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}