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International Journal of Pharmaceutical Compounding

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https://www.readbyqxmd.com/read/28346214/suspensions-as-a-valuable-alternative-to-extemporaneously-compounded-capsules
#1
Eli Dijkers, Valerie Nanhekhan, Astrid Thorissen, Hudson Polonini
The objective of this study was to determine the variation in content of 74 different active pharmaceutical ingredients (APIs) and compare it with what is known in the literature for the content uniformity of extemporaneous prepared capsules. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography, via a stability-indicating method. Samples for all active pharmaceutical ingredients were taken throughout a 90-day period and the content was determined. In total, 5,190 different samples were analyzed for 74 different active pharmaceutical ingredients at room (15°C to 25°C) or controlled refrigerated temperature (2°C to 8°C)...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346213/development-and-application-of-a-high-performance-liquid-chromatography-stability-indicating-assay-for-beyond-use-date-determination-of-compounded-topical-gels-containing-multiple-active-drugs
#2
Gregory Gorman, Simara Sokom, Lori Coward, John J Arnold
Topical gels compounded by pharmacists are important clinical tools for the management of pain. Nevertheless, there is often a dearth of information about the chemical stability of drugs included in these topical formulations, complicating the assignment of beyond-use dating. The purpose of this study was to develop a high-performance liquid chromatography photodiode array-based stability-indicating assay that could simultaneously resolve six drugs (amitriptyline, baclofen, clonidine, gabapentin, ketoprofen, lidocaine) commonly included in topical gels for pain management and their potential degradation products...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346212/stability-of-extemporaneously-prepared-hydroxycarbamide-oral-suspensions
#3
Djamila Kabiche, Issa-Bella Balde, Elyes Majoul, Sofiane Kabiche, Elodie Bourguignon, Jean-Eudes Fontan, Salvatore Cisternino, Jöel Schlatter
Hydroxycarbamide, available as tablets, is a pharmacological agent for fetal hemoglobin induction such as sickle cell anemia. The need for alternative dosage form options for patients unable to take tablets led hospital pharmacies to prepare solutions and suspensions. The objective of this study was to determine the stability of hydroxycarbamide in Ora-Plus in combination with either Ora-Sweet or Ora-Sweet SF, Ora-Blend, or Ora-Blend SF suspending agents. The studied samples were compounded into 100-mg/mL suspensions and stored in 60-mL amber glass bottles at room (22°C to 25°C) or refrigerated (4°C to 8°C) temperature...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346211/stability-of-two-antifungal-agents-fluconazole-and-miconazole-compounded-in-humco-recura-topical-cream-to-determine-beyond-use-date
#4
Pradeep Gautam, Bob Light, Troy Purvis
A novel compounding vehicle (RECURA) has previously been proven to penetrate the nail bed when compounded with the antifungal agent miconazole or fluconazole, providing for an effective treatment for onychomycosis. In this study, miconazole and fluconazole were compounded separately in RECURA compounding cream, and they were tested at different time points (0, 7, 14, 28, 45, 60, 90, and 180 days) to determine the beyond-use date of those formulations. The beyond-use date testing of both formulations (10% miconazole in RECURA and 10% fluconazole in RECURA) proved them to be physically, chemically, and microbiologically stable under International Conference of Harmonisation controlled room temperature (25°C ± 2°C/60% RH ±5%) for at least 180 days from the date of compounding...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346210/stability-of-alprostadil-in-0-9-sodium-chloride-stored-in-polyvinyl-chloride-containers
#5
Susan V McCluskey, Kylian Kirkham, Jessica M Munson
The stability of alprostadil diluted in 0.9% sodium chloride stored in polyvinyl chloride (VIAFLEX) containers at refrigerated temperature, protected from light, is reported. Five solutions of alprostadil 11 mcg/mL were prepared in 250 mL 0.9% sodium chloride polyvinyl chloride (PL146) containers. The final concentration of alcohol was 2%. Samples were stored under refrigeration (2°C to 8°C) with protection from light. Two containers were submitted for potency testing and analyzed in duplicate with the stability-indicating high-performance liquid chromatography assay at specific time points over 14 days...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346209/accuracy-considerations-in-sterile-compounding
#6
Michael J Akers
Published information about the accuracy of filling and closing operations of sterile products is limited and guidelines on the topic are very general. This article highlights the basic principles in sterile-product filling of syringes and vials. Also covered in this article are descriptions of some of the available devices for filling containers, a brief discussion of the advances in vial and syringe filling, a discussion on the advantages and disadvantages of sterile product filling methods, and a discussion on possible problems encountered during filling operations...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346208/basics-of-compounding-3d-printing-pharmacy-applications-part-1
#7
Loyd V Allen
Three-dimensional printing quickly became a standard tool in the automotive, aerospace, and consumer goods industries and, recently, has begun gaining traction in pharmaceutical manufacturing. 3D printing has steadily grown, introducing a new element into dosage form development, and has received a boost with U.S. Food and Drug Administration (FDA) approval of the 3D-printed orodispersible tablet, Spritam (levetiracetam). This part 1 of a 3-part article introduces 3D printing and its application to pharmacy...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346207/quality-control-material-safety-data-sheets
#8
Loyd V Allen
Safety Data Sheets (formerly Material Safety Data Sheets) are a system for cataloging information on chemicals, chemical compounds, and chemical mixtures and include instructions for the safe use and potential hazards associated with a particular material or product. At present, there are 16 sections of Safety Data Sheets, and these sections are discussed in this article. Two United States Pharmacopeia compounding-related chapters (<795> and <800>) refer to Safety Data Sheets, and this article provides a brief discussion on the terminology contained within those chapters...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346206/the-international-academy-of-compounding-pharmacists-introduces-a-new-president
#9
Baylor Rice
No abstract text is available yet for this article.
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346205/consultation-for-human-veterinary-and-compounded-medications
#10
Gabriella Moghadam, Lauren Eichstadt Forsythe
Providing consultation on medications is a daily responsibility for pharmacists. However, counseling components for veterinary or compounded medications can differ from those for manufactured medications for humans. This article lists the content that should be provided during consultation, describes differences between counseling for human and veterinary patients, and provides references that can be used. Because many veterinary medications are compounded, this article also provides information that should accompany compounded preparations...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346204/restructuring-the-art-of-health-by-pharmacists-formulation-designs-with-oral-vehicles-teaching-pharmacy-students
#11
Rita Benischek
Compounding pharmacists, responsible for appropriate preparation of medications, coordinate with other professionals to reach optimal therapeutic options for patients. This review summarizes proprietary oral vehicles or suspensions focusing on available information or updated data from suppliers. Research has advanced methods with revised applications, cutting-edge safety considerations, beyond-use dating provisions for technical assistance, and evidence to review and teach pharmacy students the opportunities in the choices of an oral vehicle...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346203/u-s-food-and-drug-administration-inspections-guide-to-a-successful-outcome-for-503a-sterile-compounding-pharmacies
#12
Doug Yoch
The reasons for which pharmaceutical compounding is the focus of intense state and federal scrutiny are now well known. Compounders are faced with an ever-increasing need to prove, by objective standards, the safety, purity, and potency of the formulations they dispense. They must also demonstrate their compliance with regulations often based on current good compounding practices designed for the pharmaceutical industry. In the U.S. today, rigorous unannounced state and federal inspections of compounding facilities are occurring more and more frequently...
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346202/prescription-whatever-happened-to-common-sense
#13
EDITORIAL
Loyd V Allen
No abstract text is available yet for this article.
March 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346201/a-pilot-stability-study-of-dehydroepiandrosterone-rapid-dissolving-tablets-prepared-by-extemporaneous-compounding
#14
Steven D Rush, Charlene Vernak, Fang Zhao
Dehydroepiandrosterone supplementation is used to treat a variety of conditions. Rapid-dissolving tablets are a relatively novel choice for compounded dehydroepiandrosterone dosage forms. While rapid-dissolving tablets offer ease of administration, there are uncertainties about the physical and chemical stability of the drug and dosage form during preparation and over long-term storage. This study was designed to evaluate the stability of dehydroepiandrosterone rapid-dissolving tablets just after preparation and over six months of storage...
January 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346200/compatibility-and-stability-of-rolapitant-injectable-emulsion-admixed-with-intravenous-palonosetron-hydrochloride
#15
George Wu, Stanley Yeung, Frank Chen
Neurokinin-1 receptor antagonist, 5-hydroxytryptamine-3 RA, and dexamethasone combination therapy is standard of care for the prevention of chemotherapy-induced nausea and vomiting. Herein we describe the physical and chemical stability of rolapitant injectable emulsion 166.5 mg in 92.5 mL (185 mg hydrochloride salt) admixed with palonosetron injection 0.25 mg in 5 mL (0.28 mg hydrochloride salt). Admixtures were prepared and stored in two types of container closures (110-mL Crystal Zenith plastic and glass bottles) and four types of intravenous administration sets (or intravenous tubing sets)...
January 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346199/compatibility-and-stability-of-rolapitant-injectable-emulsion-admixed-with-dexamethasone-sodium-phosphate
#16
George Wu, Stanley Yeung, Frank Chen
Neurokinin-1 receptor antagonist, 5-hydroxytryptamine-3 receptor antagonist, and dexamethasone combination therapy is the standard of care for the prevention of chemotherapy-induced nausea and vomiting. Herein, we describe the physical and chemical stability of an injectable emulsion of the Neurokinin-1 receptor antagonist rolapitant 185 mg in 92.5 mL (free base, 166.5 mg in 92.5 mL) admixed with either 2.5 mL of dexamethasone sodium phosphate (10 mg) or 5 mL of dexamethasone sodium phosphate (20 mg). Admixtures were prepared and stored in two types of container closures (glass and Crystal Zenith plastic bottles) and four types of intravenous administration tubing sets (or intravenous tubing sets)...
January 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346198/basics-of-sterile-compounding-biopharmaceutics-of-injectable-dosage-forms
#17
Michael J Akers
Biopharmaceutics studies the relationship between the drug product and what happens after the product is administered. Since the majority of injectables are administered by the intravenous route, thus avoiding the need for drug absorption, not many articles are published compared to other routes of drug administration. However, other routes of administration for drug injection are becoming more frequent because of greater commercial availability of sustained- and controlled-release drug delivery systems. This article reviews basic principles of drug absorption, distribution, metabolism, and elimination of injectable drugs and certain physicochemical and physiological factors affecting injectable drug biopharmaceutics...
January 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346197/basics-of-compounding-with-dilutions-and-concentrates
#18
Loyd V Allen
Pharmacists use various sources for obtaining the active pharmaceutical ingredient for compounding medications. In many cases, it is the pure drug (United States Pharmacopeia, National Formulary, or similar grade); in some cases, it can be a commercial dosage form; and, in some cases, it may be a dilution or concentrate. If the drug is not present at full strength, then adjustments may be necessary to obtain the required quantity of drug. Also, in many cases, it is necessary to use a dilution or a concentrate of a drug due to safety and quality reasons...
January 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346196/analytic-methods-used-in-quality-control-in-a-compounding-pharmacy
#19
Loyd V Allen
Analytical testing will no doubt become a more important part of pharmaceutical compounding as the public and regulatory agencies demand increasing documentation of the quality of compounded preparations. Compounding pharmacists must decide what types of testing and what amount of testing to include in their quality-control programs, and whether testing should be done in-house or outsourced. Like pharmaceutical compounding, analytical testing should be performed only by those who are appropriately trained and qualified...
January 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/28346195/why-you-should-become-an-international-academy-of-compounding-pharmacists-member
#20
Ernest P Gates
No abstract text is available yet for this article.
January 2017: International Journal of Pharmaceutical Compounding
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