{"title":"PreScription: Shortages Continue--Compounding Pharmacies Fill the Gap…Again!","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":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9753500","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":"Show Me the Science: A Perspective.","authors":"Anthony Grzib","doi":"","DOIUrl":"","url":null,"abstract":"","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":"9573699","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}
This article looks at taking a proactive approach in discovering inconsistencies in pharmaceutical compounding at a facility level. Details on the requirements for master formulation and compounding records in nonsterile and sterile compounding as laid out in the 2022 publications of United States Pharmacopeia Chapter <795> Pharmaceutical Compounding- Nonsterile Preparations and United States Pharmacopeia Chapter <797> Pharmaceutical Compounding-Sterile Preparations are reviewed. Following this summary, information is then presented on how to utilize the record-keeping requirements to a facility's advantage through regular auditing and reporting and how to incorporate these audits or reports into a facility's quality-assurance program to fulfill error detection and prevention requirements.
{"title":"Quality Assurance: Compounding Record Audits for Error Prevention.","authors":"Jessica Hawkins","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article looks at taking a proactive approach in discovering inconsistencies in pharmaceutical compounding at a facility level. Details on the requirements for master formulation and compounding records in nonsterile and sterile compounding as laid out in the 2022 publications of United States Pharmacopeia Chapter <795> Pharmaceutical Compounding- Nonsterile Preparations and United States Pharmacopeia Chapter <797> Pharmaceutical Compounding-Sterile Preparations are reviewed. Following this summary, information is then presented on how to utilize the record-keeping requirements to a facility's advantage through regular auditing and reporting and how to incorporate these audits or reports into a facility's quality-assurance program to fulfill error detection and prevention requirements.</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":"9573700","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}
Warts are a benign skin growth caused by the deoxyribonucleic acid virus named human papillomavirus, which infects the top layer of the skin and penetrates epithelial cells. Warts shed human papillomavirus, which can then infect other sites in the region or spread to other people. Warts can be transmitted by close skin-to-skin contact; areas of skin that are broken or cut are more susceptible to being infected with the human papillomavirus virus. Warts can also be transmitted from contaminated objects or surfaces. Most adults have developed immunity to the virus that causes warts, but children are more susceptible to warts because their bodies are less likely to have built immunity to the virus. This article discusses the pathophysiology of warts, the different types of warts, the most common treatments for warts, and provides some compounded formulas for the treatment of warts.
{"title":"Warts: Pathophysiology, Types, Treatments, and Pharmaceutical Compounds.","authors":"Robin Touprong, Tara Thompson, LaVonn A Williams","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Warts are a benign skin growth caused by the deoxyribonucleic acid virus named human papillomavirus, which infects the top layer of the skin and penetrates epithelial cells. Warts shed human papillomavirus, which can then infect other sites in the region or spread to other people. Warts can be transmitted by close skin-to-skin contact; areas of skin that are broken or cut are more susceptible to being infected with the human papillomavirus virus. Warts can also be transmitted from contaminated objects or surfaces. Most adults have developed immunity to the virus that causes warts, but children are more susceptible to warts because their bodies are less likely to have built immunity to the virus. This article discusses the pathophysiology of warts, the different types of warts, the most common treatments for warts, and provides some compounded formulas for the treatment of warts.</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":"9564879","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}
Humectants are in common use not only in pharmaceuticals but also in foods, cosmetics, etc. The proper selection of a humectant in a pharmaceutical formula depends upon the dosage form, ingredients, physical and chemical characteristics, as well as stability issues. Some of the more typical examples of humectants that are used in pharmaceuticals, foods, and cosmetics are provided in this article, as well as a more detailed list of humectants used in pharmaceuticals, including some physicochemical characteristics.
{"title":"Nonsterile Basics of Compounding: Compounding with Humectants.","authors":"Loyd V Allen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Humectants are in common use not only in pharmaceuticals but also in foods, cosmetics, etc. The proper selection of a humectant in a pharmaceutical formula depends upon the dosage form, ingredients, physical and chemical characteristics, as well as stability issues. Some of the more typical examples of humectants that are used in pharmaceuticals, foods, and cosmetics are provided in this article, as well as a more detailed list of humectants used in pharmaceuticals, including some physicochemical characteristics.</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":"9564880","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}
Mary E Fredrickson, Fady Abdlrasul, Zachary Martin, Oliva Knauf
Given the variability in compounding education provided by Doctor of Pharmacy (PharmD) programs, incorporation of compounding-focused learning experiences within pipeline programs and co-curricular education may provide students with important exposure, networking opportunities, and skill development. Compounding education can be incorporated into areas outside of the core curriculum, including pipeline programming for pre-pharmacy students and the co-curriculum for current pharmacy students. This article, which is a perspective commentary, will discuss suggestions for designing and implementing these types of learning opportunities, including considerations for faculty and budgets and related benefits for learners. These ideas will be discussed in the context of examples provided by a college of pharmacy who has implemented these learning experiences. To ensure well-trained pharmacists continue to pursue compounding careers, it is vital that pharmacy programs provide ample opportunities for student exposure and training in this area. Pharmacy programs are encouraged to incorporate compounding- focused learning experiences within pipeline programming and the co-curriculum. Future research is needed to investigate the impact of such experiences on students' compounding knowledge and skills and their pursuit of compounding careers.
{"title":"Opportunities for Pipeline Programming and Co-curriculum Learning Experiences--A Perspective Commentary.","authors":"Mary E Fredrickson, Fady Abdlrasul, Zachary Martin, Oliva Knauf","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Given the variability in compounding education provided by Doctor of Pharmacy (PharmD) programs, incorporation of compounding-focused learning experiences within pipeline programs and co-curricular education may provide students with important exposure, networking opportunities, and skill development. Compounding education can be incorporated into areas outside of the core curriculum, including pipeline programming for pre-pharmacy students and the co-curriculum for current pharmacy students. This article, which is a perspective commentary, will discuss suggestions for designing and implementing these types of learning opportunities, including considerations for faculty and budgets and related benefits for learners. These ideas will be discussed in the context of examples provided by a college of pharmacy who has implemented these learning experiences. To ensure well-trained pharmacists continue to pursue compounding careers, it is vital that pharmacy programs provide ample opportunities for student exposure and training in this area. Pharmacy programs are encouraged to incorporate compounding- focused learning experiences within pipeline programming and the co-curriculum. Future research is needed to investigate the impact of such experiences on students' compounding knowledge and skills and their pursuit of compounding careers.</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":"9564876","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}
Intravenous admixture compounding is a common practice in most hospitals throughout the world, regardless of the country. The compounding of intravenous medications, however, involves risk, as there is a high potential for error due to their complexity in compounding. Also, working in an aseptic environment itself poses issues for the compounder. This article in an overall series on the topic of intravenous admixture compounding will discuss the vehicles commonly used in intravenous admixtures, as well as the small-volume parenterals often used in compounding intravenous admixtures.
{"title":"Sterile Basics: Intravenous Admixture Compounding, Part 2: Parenteral Vehicle Considerations.","authors":"Loyd V Allen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Intravenous admixture compounding is a common practice in most hospitals throughout the world, regardless of the country. The compounding of intravenous medications, however, involves risk, as there is a high potential for error due to their complexity in compounding. Also, working in an aseptic environment itself poses issues for the compounder. This article in an overall series on the topic of intravenous admixture compounding will discuss the vehicles commonly used in intravenous admixtures, as well as the small-volume parenterals often used in compounding intravenous admixtures.</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":"9564881","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}
Dimercaptosuccinic acid, or succimer, is an oral, heavy-metal chelating agent used to treat lead and heavy-metal poisoning. Although the drug is mainly used for the treatment of lead intoxication, initial data has shown encouraging results for the treatment of mercury and arsenic poisoning as well. This article focuses on the use of dimercaptosuccinic acid as a chelating agent and provides some general information on dimercaptosuccinic acid.
{"title":"Dimercaptosuccinic Acid: Summary of Evidence.","authors":"Jamarius Carvin, Tara Thompson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Dimercaptosuccinic acid, or succimer, is an oral, heavy-metal chelating agent used to treat lead and heavy-metal poisoning. Although the drug is mainly used for the treatment of lead intoxication, initial data has shown encouraging results for the treatment of mercury and arsenic poisoning as well. This article focuses on the use of dimercaptosuccinic acid as a chelating agent and provides some general information on dimercaptosuccinic acid.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9232910","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}
Yashoda V Pramar, Tarum K Mandal, Levon A Bostanian, Cyndy Kader, Tommy C Morris, Richard A Graves
Pyrimethamine is an antiparasitic compound available only in tablet form for oral administration. A review of the therapeutic uses of pyrimethamine 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 pyrimethamine currently exists. Pyrimethamine is available commercially only as 25-mg tablets. 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 pyrimethamine suspension in 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. A robust stability-indicating high-performance liquid chromatographic assay for the determination of the chemical stability of pyrimethamine in PCCA SuspendIt was developed and validated. Suspensions of pyrimethamine were prepared in PCCA SuspendIt at a 2-mg/mL concentration, selected to provide flexibility in customizing individual doses. 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, and 42. 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 pyrimethamine concentrations did not go below 96% of the label claim (initial drug concentration) at both temperatures studied. No microbial growth was observed. pH values remained constant. The viscosity of the suspensions allowed easy re-dispersal of the drug particles upon shaking. This study demonstrates that pyrimethamine is physically, chemically, and microbiologically stable in PCCA SuspendIt for 42 days stored in the refrigerator and at room temperature, thus providing a viable, compounded alternative for pyrimethamine in a liquid dosage form.
{"title":"Physicochemical and Microbiological Stability of Pyrimethamine in Paraben-free PCCA Base, SuspendIt.","authors":"Yashoda V Pramar, Tarum K Mandal, Levon A Bostanian, Cyndy Kader, Tommy C Morris, Richard A Graves","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Pyrimethamine is an antiparasitic compound available only in tablet form for oral administration. A review of the therapeutic uses of pyrimethamine 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 pyrimethamine currently exists. Pyrimethamine is available commercially only as 25-mg tablets. 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 pyrimethamine suspension in 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. A robust stability-indicating high-performance liquid chromatographic assay for the determination of the chemical stability of pyrimethamine in PCCA SuspendIt was developed and validated. Suspensions of pyrimethamine were prepared in PCCA SuspendIt at a 2-mg/mL concentration, selected to provide flexibility in customizing individual doses. 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, and 42. 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 pyrimethamine concentrations did not go below 96% of the label claim (initial drug concentration) at both temperatures studied. No microbial growth was observed. pH values remained constant. The viscosity of the suspensions allowed easy re-dispersal of the drug particles upon shaking. This study demonstrates that pyrimethamine is physically, chemically, and microbiologically stable in PCCA SuspendIt for 42 days stored in the refrigerator and at room temperature, thus providing a viable, compounded alternative for pyrimethamine in a liquid dosage form.</p>","PeriodicalId":14381,"journal":{"name":"International journal of pharmaceutical compounding","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9239382","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}