International journal of pharmaceutical compounding最新文献

{"title":"Compatibility of Various Hormones in Phytobase and HRT Heavy Cream Bases.","authors":"Sarah Taylor, Rodney Haselhorst","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The release of United States Pharmacopeia Chapter <800> and the revisions to United States Pharmacopeia Chapter <795> (official November 1, 2023) indicates a changing regulatory climate and a trend towards increasingly high standards for the extension of beyond-use dates beyond the default recommended by the guidelines. Given the increased scrutiny and the additional requirements for establishing extended beyond-use dates, additional testing is required to help pharmacies provide the best formulations with scientifically robust data to support an extended beyond-use date for patient convenience. The objective of this study was to demonstrate the suitability of two vehicles, Phytobase and HRT Heavy, for compounded hormone therapy by evaluating the stability and antimicrobial effectiveness of the vehicles with common combinations of hormones.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 1","pages":"75-81"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671728","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":"Extemporaneous Topical Minoxidil Solutions for the Treatment of Androgenetic Alopecia- Stability Studies and Incorporation Tests of Active Pharmaceutical Ingredients in Aloplus Total Base.","authors":"Antonio Spennacchio, Angela Assunta Lopedota, Antonio Lopalco, Annalisa Cutrignelli, Flavia Maria la Forgia, Sergio Fontana, Massimo Franco, Nunzio Denora","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Minoxidil is one of the most employed active pharmaceutical ingredients for the  treatment of androgenetic alopecia. The authors propose a new method for production of minoxidil lotions using Aloplus Total. The latter is a propylene glycol-free liquid base in which the presence of hydroxypropyl-ß-cyclodextrin and ethanol allows the solubilization of high drug amounts. Minoxidil intrinsic solubility in the base was determined, and a comprehensive chemical and physical stability study was conducted on 8% w/w minoxidil lotions. Incorporation tests of different active pharmaceutical ingredients that can be combined to 5% w/w minoxidil were also carried out. The analyses showed that minoxidil intrinsic solubility in the new base was 85.93 mg/mL ± 4.17 mg/mL (8.64% w/w ± 0.42% w/w) at 25°C, and the topical lotions were found to be physically and chemically stable for more than 180 days when stored at 25°C or 40°C. Incorporation tests of several active pharmaceutical ingredients also were successful, indicating that Aloplus Total is a liquid vehicle also useful for the preparation of minoxidil-based topical lotions for a synergistic treatment of androgenetic alopecia.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 1","pages":"68-73"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671732","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 1","pages":"44-55"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671735","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":"Hormone Treatment Options for Males: What to do for Men with Low Testosterone.","authors":"Bruce Biundo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Male hypogonadism is a condition that is receiving increasing medical scrutiny, resulting in research producing results favorable to the consideration of maintaining physiological levels of testosterone. As healthcare professionals interested in the health and welfare of a significant portion of the population, surely compounding pharmacists are interested in what can be done for men with this condition to help these patients improve their quality of life and long-term health. This article discusses the various ways that men's testosterone levels can be raised and provides insight into the importance of androgen-estrogen balance.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 1","pages":"28-32"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671733","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: IJPC is now all Digital.","authors":"Loyd V Allen","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 1","pages":"4"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671734","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":"Differentiation and Treatment of Hypothyroidism, Functional Hypothyroidism, and Functional Metabolism.","authors":"Jim Paoletti","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Less than optimal thyroid effects can occur for many reasons, including lack of production, excessive binding, reduced conversion to the active form of thyroid, poor intracellular transport, poor receptor response, or autoimmune and toxicity issues. Differentiation of where the problem or problems causing the symptoms of hypothyroidism to occur is a key to the return to optimal thyroid response and successful treatment outcome. The concept of hypothyroidism, functional hypothyroidism, and functional hypometabolism as an alternative method to describe classical subclinical hypothyroidism symptoms according to the source of the malfunction are discussed in this article. The author also presents a unique method of using standard thyroid measurements to determine the areas of dysfunction and discusses the possible reasons for low production, excessive binding, poor conversion, and suboptimal receptor response. Appropriate treatment options for each area are discussed, including nutritional requirements. Thyroid replacement therapy options are presented and individualization of therapy based on need established with use of the thyroid gradient levels is discussed. Individualization of thyroid therapy will often require the use of compounded T3 or T4/T3 combination therapy. Compounding thyroid replacement allows for avoiding fillers that can interfere with absorption, unwanted diluents, unknown or nonstandardized ingredients from animal sources, providing more sustained action with less side effects, and individualizing the ratio of T4 and T3 initially, and as improvements are made in the patient's ability to convert T4 to T3.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 1","pages":"34-43"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671729","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":"Extemporaneous Compounding of Low-strength Aspirin Capsules for Desensitization Protocols.","authors":"Carly Messenger, Bailey Soper, Kara Cutaia, Fang Zhao","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Aspirin is a non-steroidal, anti-inflammatory drug used for a range of indications. For patients with aspirin hypersensitivities, a desensitization procedure may be prescribed, and the initial low doses of <81 mg need to be provided by compounded preparations. Compounding with aspirin is associated with stability challenges due to its poor chemical stability. Additionally, low-strength preparations often exhibit dosage accuracy and uniformity issues. This study was designed to assess the feasibility of compounding low-strength aspirin capsules for the use in desensitization protocols. Aspirin capsules of 40-mg, 10-mg, 3-mg, and 1-mg strengths were prepared by manual filling of dry powders. Formulations were kept as simple as possible for ease of compounding, and the ingredients and compounding procedures were carefully selected to minimize the moisture content and to optimize the dosage accuracy. For the 40-mg and 10-mg capsules, two formulations were tested, using pure drug or crushed tablet powder. For the 3-mg and 1-mg capsules, only one formulation was tested, using a 5% mixture of pure drug and cellulose. All formulations were filled into hydroxypropyl methylcellulose capsule shells and stored at room temperature for 90 days. A  stability indicating, high-performance liquid chromatography method was used to analyze the quality of the capsules. The initial potency results of all capsule formulations were within 100% to 105% of the label claim, and the standard deviation was <3% for all formulations except the 1-mg strength (7%). The use of crushed tablet powder over pure drug powder appeared to reduce the potency variability, probably due to the larger fill weight per capsule. Upon storage at room temperature, the 40-mg and 10-mg formulations retained >90% of the label claim for up to 90 days, but the 3-mg and 1-mg formulations retained >90% of the label claim for up to only 31 days. Low-strength aspirin capsules were prepared successfully by compounding with a beyond-use date of at least 31 days at room temperature. However, the overall trend confirmed the challenges of achieving dosage uniformity and aspirin stability at 3-mg and 1-mg strengths. For general application in compounding pharmacies, trial batches are recommended with proper analytical testing.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 1","pages":"82-86"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671731","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":"Establishing a Rationale for Compounding Hormone Replacement Therapy.","authors":"Bruce Biundo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Why compound bioidentical hormones? Are there no similar commercial products? What is unique about the options compounding pharmacists offer compared with what is out in the marketplace? These are questions that physicians and other practitioners are asking, and it is very important that we have intelligent, well-thought answers when we respond. Times have changed, and the challenges we face today in marketing our compounded therapies are not the same as those of twenty years ago. Premarin is no longer at the top of the heap, and there are topical, commercial products that contain bioidentical estradiol, and capsules that contain the same progesterone that we use. Our compounding advantage comes from our abilities to prepare unique patient-specific products, and, very importantly, from our growing understanding of hormone receptors; we now know there are two main estrogen receptors, 1) estrogen receptor alpha and 2) estrogen receptor beta, and the growing knowledge base associated with the discovery of estrogen receptor beta is quite significant.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 1","pages":"22-27"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671730","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":"The Physiologic Role and Use of Estriol.","authors":"Jim E Paoletti","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Obtaining estrogen balance with a physiologic estriol and estradiol ratio is an important aspect of physiologic bioidentical hormone restoration therapy. Risks, including that of breast cancer, should be minimized while attempting to obtain the protective benefits and symptom management with therapy. Estriol plays a central role in protecting against breast cancer and should be considered an integral part of therapy for any patient with lower than normal physiologic levels.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"28 1","pages":"16-21"},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139671736","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":"Environmental Sterility-control Practices in Selected Retail Pharmacies in Sri Lanka: A Study in Kandy District.","authors":"Tmiuk Tennakoon, Anoya Thayananthan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Maintaining the microbial quality of the environment is crucial in pharmaceutical institutions, especially community pharmacies, since they have a direct relationship with patients. The sterility of the environmental surfaces of pharmacies can be maintained by proper cleaning and disinfecting. Microbial contamination is the primary reason for product spoilage or deterioration. The present study was carried out to assess the sanitation practices of pharmacies on the maintenance of cleanliness followed by isolation and identification of microorganisms from surface and air samples of selected pharmacies. All the pharmacies followed daily sanitization practices in the pharmacy premises and surrounding environment. However, only 20% of the pharmacies cleaned their equipment daily. In total, 33 bacterial species were identified from the pharmacies. Of these, 31 were Gram-positive (29 coagulase-negative staphylococci) and 2 Streptococcus spp., while 2 were Gram-negative (Pseudomonas aeruginosa and Proteus vulgaris). The colony-forming unit count of air samples after one-hour exposure under uni-directional air flow was less than 20 except from one pharmacy which was 59. Significant statistical associations were not observed between the presence of separate extemporaneous preparation rooms, separate counseling places, type of disinfectant, spillage management, and the growth of organisms in the pharmaceutical products and complaints received for spoiled products. However, some pharmacies under investigation were confirmed to have had poor sterility-control practices since they showed the growth of fastidious organisms both Gram-negative bacilli and Gram-positive cocci of which the latter was in more abundance.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":"27 6","pages":"503-511"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138803705","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}