International journal of pharmaceutical compounding最新文献

{"title":"Case Report: Wound Care of a Diabetic Foot Ulcer.","authors":"Tom Wynn, Chad Thompson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Wound care is one of the main concerns of patients with diabetes. This case involves a 65-year-old woman with a wound (4 cm x 2 cm) on her right foot, underneath the big toe. The patient had not been successful in healing this wound using conventional preparations for a year. A decision was made to compound a wound-care gel formulation, and two preparations were compounded. One contained phenytoin 3% and misoprostol 0.0024% gel and was used for wound healing. The patient was instructed to cover the wound twice daily with about 0.2 mL of this preparation. The other preparation was nifedipine 10% in a Pluronic lecithin organogel 20%. The patient was instructed to apply 0.6 mL twice daily around the wound and callous surrounding the wound and up the foot to increase circulation to the wound area. Saline rinses, which the patient had already been using, were continued as before (with application of the nifedipine gel afterward, followed by application of the phenytoin/misoprostol formulation). The wound was covered with sterile gauze. Healing was seen almost immediately and was quite advanced after 8 weeks. During 4 additional weeks, final closure of the wound occurred. Total healing time for the wound was 17 weeks. The author concludes that wound gels are effective in healing diabetic foot ulcers and that this is a promising therapeutic alternative for patients with refractory foot ulcers.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 6","pages":"455-458"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142789463","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":"Compatibility of 17-α-Estradiol, Betamethasone, Finasteride, Melatonin, Prednicarbate, and Spironolactone in TrichoFoam™ - a Foaming Vehicle for Personalized Alopecia Treatments.","authors":"Bruna Marianni, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objective: </strong>This study evaluates the physicochemical compatibility of six active pharmaceutical ingredients (APIs) - 17-a-estradiol, betamethasone, finasteride, melatonin, prednicarbate, and spironolactone - in TrichoFoam™, a foaming vehicle designed for personalized alopecia treatments.</p><p><strong>Background: </strong>Alopecia, a condition impacting around 2% of the global population, can benefit from more effective and patient-friendly treatments. TrichoFoam™ represents a personalized medicine approach that utilizes a foam base to enhance the delivery and efficacy of topical treatments.</p><p><strong>Methods: </strong>The physicochemical compatibility was assessed using High-Performance Liquid Chromatography (HPLC) and Ultra-High Performance Liquid Chromatography (UHPLC) to ensure that the APIs remain stable and effective within TrichoFoam™. Products evaluated were: 17-a-estradiol 0.025% - 0.05%, betamethasone 0.1% - 0.2%, finasteride 0.01% - 0.25%, melatonin 0.05% - 0.5%, prednicarbate 0.1%, and spironolactone 1.0%. Forced degradation studies and stability-indicating analyses were conducted to determine the APIs' stability under various conditions.</p><p><strong>Results: </strong>The beyond-use dates found were: 17-a-estradiol 0.025% = 120 days; 17-a-estradiol 0.05%= 14 days; Betamethasone 17-valerate 0.1% = 180 days; Betamethasone 17-valerate 0.2% = 120 days; Finasteride 0.01% to 0.25% = 120 days; Melatonin 0.05% to 0.5%= 60 days; Prednicarbate 0.1% = 60 days; Spironolactone 1.0% = 14 days. The APIs demonstrated satisfactory compatibility with TrichoFoam™, with no significant chemical interactions or stability issues observed. Stability studies showed that the APIs maintained their efficacy within the foam base over time, with acceptable recovery percentages.</p><p><strong>Conclusion: </strong>This study can further support the use of TrichoFoam™ as a viable vehicle for delivering multiple APIs in a personalized alopecia treatment regimen. The compatibility and stability of the APIs within this formulation offer a promising advancement in tailored alopecia treatments, potentially improving patient adherence and therapeutic outcomes.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 6","pages":"520-529"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142789478","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":"Physicochemical and Microbiological Stability of Extemporaneously Compounded Chloral Hydrate Oral Liquid Dosage Forms in PCCA Base, SuspendIt®.","authors":"Yashoda V Pramar, Courtaney Davis, Kendice Ip, Daniel Banov","doi":"","DOIUrl":"","url":null,"abstract":"&lt;p&gt;&lt;p&gt;Chloral hydrate is a hypnotic, sedative and anxiolytic (non-benzodiazepine) drug that is commonly administered to children prior to procedures such as dental sedation. It is also indicated for nocturnal sedation in all types of patients and especially for the ill, the young, and the elderly patients. A review of the therapeutic uses of chloral hydrate reveals the need for flexibility in dosing, especially in children. However, chloral hydrate is commercially available as a syrup in one fixed strength containing 100-mg/mL. Due to a lack of age-appropriate commercial drug products, an alternative extemporaneously compounded oral liquid from pure drug powder with stability documentation over a bracketed range of 25-mg/mL to 100-mg/mL was developed to provide a flexible, customizable option to meet unique patient needs with convenient and accurate dosing options for pediatric and adult patients. The purpose of the current study was to develop a stability-indicating assay for the analysis of chloral hydrate and to determine the physicochemical and microbiological stability of chloral hydrate in PCCA SuspendIt, a suspending vehicle developed by the Professional Compounding Centers of America (PCCA), Houston, Texas, for use by compounding pharmacists. This base is a sugar-free, paraben-free, dye-free, and gluten-free thixotropic vehicle containing a natural sweetener obtained from the monk fruit. A robust stability-indicating ultra-high-performance liquid chromatographic assay (UPLC) for the determination of the chemical stability of chloral hydrate in PCCA SuspendIt was developed and validated. The study design included two chloral hydrate concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. Solutions of chloral hydrate were prepared from pure drug powder in PCCA SuspendIt at 25-mg/mL and 100-mg/mL concentrations, to represent a range in 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): 14, 30, 60, 90, and 180. Physical data such as pH and appearance were noted. Samples were also tested for microbiological stability. A stable extemporaneous product is defined as one that retains at least 90% of the label drug concentration throughout the sampling period and is protected against microbial growth. Using this criterion, no significant degradation of the chloral hydrate was observed over the 180-day test period for either concentration at room temperature and in the refrigerator. Drug concentrations were at, or above 96% of the labeled concentrations. No microbial growth was observed. pH values remained fairly constant. This study demonstrates that chloral hydrate is physically, chemically, and microbiologically stable in PCCA SuspendIt for 180 days at room temperature and in the refrigerator at both concentrations","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 6","pages":"492-501"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142789486","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":"Taste Masking Study of Orally Disintegrating Film (ODF) Formulations Containing Memantine Hydrochloride.","authors":"Ganesan Gobal, Hiu Ching Phang, Zhi Qi Ng, Ying Hui Loke, Yik Ling Chew, Abm Helal Uddin, Siew-Keah Lee, Vijayakumar Lakshminarayanan, Kai Bin Liew, Shamima Abdul Rahman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Geriatric patients have difficulty to comply to their medication regimen due to complicated medication administration schedule, dysphagia, reduced ability to swallow tablets and dementia. This is particularly more challenging among the Alzheimer Disease's patients. Therefore, a model drug, memantine hydrochloride has been formulated into an orally disintegrating film (ODF) for easier consumption. However, bitter taste of memantine hydrochloride needs to be solved first if the drug is formulated into an ODF. The objective of this study is to taste mask memantine hydrochloride ODF and conduct a palatability study to evaluate the palatability of the dosage form. Memantine hydrochloride ODF was prepared using solvent casting method followed by freeze drying. The polymeric base consisted of Guar gum, PEG 400 and wheat starch in solvent water, with varying amounts of Aspartame or Acesulfame K for taste masking. The freeze-dried memantine hydrochloride ODFs were evaluated for tensile strength, in-vitro disintegration time, average thickness, dissolution, memantine hydrochloride content, and palatability. Formulation M7 was selected as the best taste masked formulation. Aspartame 30 mg is sufficient to cover the bitter taste of memantine hydrochloride in ODF form. A taste masked memantine hydrochloride ODF of dimensions 20 x 20 mm containing 30mg of aspartame was successfully developed. This formulation has average values for tensile strength 0.03 (0.01) kPa, folding endurance 351.92 (4.82) flips, thickness 0.94 (0.02) mm, and disintegration time 34.15 (2.16) seconds.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 5","pages":"402-407"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465531","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":"Compatibility of Cetirizine Hydrochloride, Dutasteride, Hydrocortisone Acetate, Nicotinamide, Progesterone, and Pyridoxine Hydrochloride in TrichoSolTM, A Natural Vehicle for Hair Solutions.","authors":"Hudson C Polonini, Sarah Taylor, Carolina C V Silva","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Compounding pharmacies commonly use ready-to-use vehicles such as TrichoSolTM to produce hair solutions for alopecia. However, chemical and microbiological compatibility are paramount to be determined so those can be safely implemented as the vehicle of choice. This study aimed to assess the physical-chemical and microbiological stabilities of selected active pharmaceutical ingredients in TrichoSolTM. For that, HPLC analyses and Antimicrobial Effectiveness Testing were conducted in bracketed studies. The beyond-use dates (BUDs) found were: 180 days for cetirizine hydrochloride 0.5%-2.0%, dutasteride 0.1%, hydrocortisone acetate 0.5%, nicotinamide 0.25%-0.50%, progesterone 1.0%, and pyridoxine hydrochloride 0.25%-5.0%. BUDs of 150 days were observed for hydrocortisone acetate 1.0%, 120 days for Dutasteride 0.25%, and 90 days for progesterone 2.5%.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 5","pages":"440-447"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465515","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":"Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom.","authors":"Eric S Kastango, Kate Douglass, Kedar Patel, Babak Givehchi, Paul Brister, Jay Postlewaite, Laura Taraban","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Compounders worldwide are responsible for ensuring that the sterile preparations they dispense are pure, potent, and safe. To achieve that result, proper cleaning and disinfection of International Organization for Standardization controlled environments must occur. Because those tasks must be performed according to established standards, the compounding pharmacist must research regulatory requirements and appropriate products for use. In this report, we focus on U.S. regulations, guiding entities, and effective products that enable compliance with the increasingly stringent procedures required for pharmaceutical compounding. We also review cleaning and disinfecting processes, discuss the importance of correctly choosing and using disinfectants and/ or sporicidal disinfectants with surface claims in the cleanroom, and provide answers to questions frequently asked by staff who use those agents. In addition, we profile specific disinfectants that are compliant with United States Pharmacopeia Chapter <797> and current good manufacturing practice standards. Biological safety cabinets and compounding aseptic containment isolators must undergo an additional process that deactivates hazardous drug residues and removes them from the interior surfaces of those devices before they are cleaned and disinfected, but that discussion is beyond the scope of this article.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 5","pages":"383-393"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465529","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 Allopurinol in Extemporaneously Compounded Oral Suspensions with Oral Mix and Oral Mix SF.","authors":"Mihaela Friciu, Erica Cull, Grégoire Leclair","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Allopurinol is a xanthine oxidase inhibitor used to reduce the production of uric acid in the body. Commercial tablets may be crushed and suspended in a compounding vehicle and provide an alternative dosage form for patients with difficulty swallowing, such as children. The stability of a compounded preparation of allopurinol 20 mg/mL was evaluated in ready-to-use vehicles, namely Oral Mix and Oral Mix SF. A stability indicating HPLC method was developed and validated to assess the amount of allopurinol over time. Formulations were stored in tightly closed, light resistant plastic containers at both room temperature and refrigerated conditions. Chemical analysis, pH measurement and organoleptic assessment were performed at predetermined time points up to 90 days. Antimicrobial effectiveness testing was also performed after 90 days of storage at room temperature. The stability study demonstrated that the allopurinol 20 mg/mL suspensions prepared from commercial tablets in Oral Mix and Oral Mix SF was stable up to 90 days under the tested conditions.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 5","pages":"408-412"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465530","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":"Crushability Analysis of Immediate-Release Oral Tablets and Capsules from the 2020-22 FDA Novel Drug Approvals.","authors":"Kamaladdin Saei, Anne Schweighardt, Fang Zhao","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Purpose: </strong>Healthcare providers often need to explore alternative options for patients who are unable to swallow whole tablets or capsules. Many newly approved immediate-release (IR) solid oral drugs carry a general \"do-not-crush\" warning or similar statements in their labeling without any explanations. A 2021 publication by Uttaro et al. presented a crushability analysis strategy for risk assessment and demonstrated its utility for some uncertain IR drugs on the ISMP do-not-crush list. This article provides an update on the topic and performs the crushability analysis of newly FDA-approved drugs.</p><p><strong>Methods: </strong>The novel drug approvals from 2020-22 were obtained from the FDA website. The IR oral tablets and capsules were extracted from the lists and subjected to crushability analysis. The scope of crushing activity was defined as crushing the tablets or capsule contents using a mortar and pestle, followed by suspending the powder in plain water at room temperature and administering the dose within 2 hours. The crushability analysis employed a checklist of questions regarding special dosage form design, hazardous drug status, stability & pharmacokinetics (PK), unofficial data from manufacturers, and availability of alternative dosage forms. The FDA-approved product labels were used as the main references for the analysis. NIOSH publications, FDA Orange Book, patents, and scientific literature were used for selected drugs.</p><p><strong>Results: </strong>From 2020 to 2022, 52 novel drug approvals were identified as IR oral tablets and capsules. Among them, 2 products were discontinued, and 10 already included specific manipulation instructions on their labels. The remaining 40 products had either a general \"do-not-crush\" statement or no information regarding crushability on the labels. The crushability analysis of these 40 products revealed that 23 products exhibited a low risk for crushing. However, the remaining 17 products were not suitable for crushing due to mostly stability/PK concerns. Four manufacturers had unofficial data related to crushing or mixing with liquids/soft foods, and none of the products had alternative oral liquid dosage forms.</p><p><strong>Conclusion: </strong>The crushability analysis strategy was updated and applied to 40 IR oral tablets and capsules approved by FDA during 2020-22. The summary table and highlighted examples serve as a practical resource for pharmacists and other healthcare providers to make informed decisions regarding dosage form manipulation to facilitate dose administration in patients with difficulty swallowing solids.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 5","pages":"364-372"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465416","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":"Quality Control: Water Activity Considerations for Beyond-use Dates.","authors":"Loyd V Allen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>There are minimum levels of water activity that are required for growth of bacteria and molds. Water activity is the ratio of vapor pressure of water in a product to pure water at the same temperature. Pure distilled water has a water activity of 1. Water activity is also a measure of water in a material that is available to react with or attach itself to other material; it is also called \"free\" water while the unavailable water is called \"bound\" water. Higher water activity substances tend to support more microorganisms; bacteria usually require water activity values of at least 0.91 and fungi at least 0.6. Every microorganism has a limit of water activity below which it will not grow. To lower water activity, one can add or change the concentrations of ingredients such as sodium chloride, sucrose, alcohol, propylene glycol, or glycerin so the preparation becomes self-preserving. Also, if the preparation has too high a water activity and the addition of other substances to lower the water activity, then a preservative may be required for the preparation. Nonaqueous liquids or dry solids will not support spore germination or microbial growth due to their low water activity.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 5","pages":"376-381"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465528","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":"Compatibility of Active Pharmaceutical Ingredients in Cleoderm™: A Comprehensive Study for Enhanced Topical Dermatological Treatments.","authors":"Bruna Marianni, Mercedeh Mansourian, Savvas Koulouridas, Hudson Polonini","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>This study investigates the compatibility and stability of active pharmaceutical ingredients (APIs) in Cleoderm™, a dermatological cream designed for the treatment of acne vulgaris, hyperpigmentation, dermatitis and other skin conditions. Cleoderm™ is formulated with hyaluronic acid and Cleome gynandra L., recognized for their sebum-regulating and anti-inflammatory properties. Complementary ingredients, such as palmitoyl tripeptide-8, bisabolol, and functional oils, contribute to the cream's antioxidant and anti-inflammatory effects.</p><p><strong>Method: </strong>High-performance liquid chromatography (HPLC) was employed to assess the compatibility of APIs in Cleoderm™. Forced degradation studies were conducted to evaluate API stability under diverse stress conditions.</p><p><strong>Result: </strong>The study established beyond-use dates (BUDs) for the tested formulations stored at room temperature. Adapalene (0.1%), dapsone (5% to 10%), and hydroquinone (10%) exhibited BUDs of 180 days. Throughout this period, no discernible physical alterations were observed in the formulations, and their chemical stability remained within acceptable parameters. Comprehensive microbiological assessments affirmed the efficacy of the preservative system.</p><p><strong>Conclusion: </strong>These findings underscore Cleoderm™'s potential as a dependable vehicle for compounded dermatological preparations. The study underscores the significance of continuous stability assessments and quality control protocols in formulating personalized and efficacious treatments for acne vulgaris and other inflammatory dermatoses. Progress in this field holds promise for enhancing therapeutic options and outcomes for individuals affected by these conditions.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 5","pages":"413-422"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465514","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}