International journal of pharmaceutical compounding最新文献

This article on the topic of sterile and nonsterile repackaging is based on the content of United States Pharmacopeia 35-National Formulary 30 and how the respective official chapters of the publication relate to pharmacy compounding and practice. The article differentiates between commercial repackagers and pharmacists that repackage in their pharmacy for their patients. It also discusses the standards for packaging and the beyond-use dates that should be assigned.

Bethanechol chloride is a cholinergic agent used to treat acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. It is available in the United States as tablets for oral administration in four dosage strengths: 5 mg, 10 mg, 25 mg, and 50 mg. A review of the therapeutic uses of bethanechol chloride 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 bethanechol chloride currently exists. An extemporaneously compounded suspension from pure drug powder or commercial tablets 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 bethanechol chloride suspensions using two brands of commercially available tablets (Amneal and Upsher-Smith) 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 bethanechol chloride concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. A robust stability-indicating ultra-high-performance liquid chromatographic assay for the determination of the chemical stability of bethanechol chloride in PCCA SuspendIt was validated. Suspensions of bethanechol chloride were prepared from the tablets in PCCA SuspendIt at 1-mg/mL and 5-mg/mL concentrations, selected to represent a range within which the drug is commonly dosed. Samples were stored in amber plastic prescription bottles at room temperature (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 also noted. Microbiological stability was tested. 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. Using this criterion, no significant degradation of the bethanechol chloride was observed over the 180-day test period for either concentration at room temperature. Drug concentrations were at, or above 93% of initial values for both brands of commercially available tablets. No microbial growth was observed. pH values remained fairly constant. This study demonstrates that bethanechol chloride tablets are physically, chemically, and microbiologically stable in PCCA SuspendIt for 180 days at room temperature at both concentrations studied, thus providing a viable, compounded alternative for bethanechol chloride in a liquid dosage form, with an extended BUD to meet patient needs.

Information on the physical compatibility of intravenous (IV) medications is vital for patient care and safety in acute care settings. Drug information resources list ondansetron and nafcillin as IV compatible, however, bolus concentrations of ondansetron are not reported. This study investigated the in vitro physical compatibility of bolus and infusion concentrations of ondansetron hydrochloride with nafcillin sodium. Two admixtures were prepared: 1) ondansetron hydrochloride 2 mg/mL and nafcillin sodium 20 mg/mL, and 2) ondansetron hydrochloride 0.16 mg/mL and nafcillin sodium 20 mg/mL. The admixtures were prepared in triplicate using aseptic technique according to manufacturer guidance and stored at room temperature (22-23 °C) for up to 24 hours. Admixtures were examined for visual precipitation, turbidity, and pH at baseline and at 1, 5, 8, and 24 hours. Admixture 1 developed a haze immediately after mixing, which was sustained over 24 hours. There was a demonstrative change in absorbance after 1 hour, but pH remained stable until hour 24. Admixture 2 developed a haze at 5 hours, but the absorbance and pH remained stable until hour 24; a decrease in the pH was observed in all samples at hour 24. This in vitro study revealed that ondansetron hydrochloride 2 mg/mL and nafcillin sodium 20 mg/mL are not physically compatible when administered through the same IV line. No demonstrative change was observed with ondansetron hydrochloride 0.16 mg/mL and nafcillin sodium 20 mg/mL; however, concurrent administration of these medications is questionable when delivered through an IV line for periods of five hours or longer.

The release of USP chapter <800> Hazardous Drugs -Handling in Healthcare Settings and the major revisions to USP <795> Pharmaceutical Compounding -Nonsterile Preparations in 2023 rendered many studies previously used to justify extended beyond use date (BUD) no longer sufficient. To provide compounders with high quality evidence to support physical, chemical, and microbial stability of hormone preparations in two aqueous cream vehicles, Phytobase™ and HRT Heavy™, we set out to perform stability indicating testing and antimicrobial effectiveness testing (AET) per USP <51> on 12 different combinations bracketed in high and low concentrations (for a total of 24 tested formulas) of common topical and transdermal hormones. In this study we discuss the suitability of Phytobase™ and HRT Heavy™ for compounded hormone therapy (CHT) and the compatibility of these vehicles with hormones including estriol, estradiol, testosterone, progesterone, and dehydroepiandrosterone both alone and in combination.

The Alliance for Pharmacy Compounding recently released four resource documents aimed at shaping compounding best practices and regulatory compliance.

Clonidine Hydrochloride is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. A review of the therapeutic uses of clonidine hydrochloride 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 clonidine hydrochloride currently exists. 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 clonidine hydrochloride 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 clonidine hydrochloride 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 clonidine hydrochloride in PCCA SuspendIt was developed and validated. Suspensions of clonidine hydrochloride were prepared in PCCA SuspendIt at 20-mcg/mL and 100-mcg/mL concentrations, selected to represent a range within which the drug is commonly dosed. Given the potent nature of the drug, a 2% triturate of clonidine hydrochloride in microcrystalline cellulose was used to prepare the samples. 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, 42, 63, 91, 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. Using this criterion, no significant degradation of the clonidine hydrochloride was observed over the 182-day test period for either concentration under refrigerated conditions. Drug concentrations were at, or above 94.6% of initial values. However, at room temperature the concentration of the 20-mcg/mL samples dropped below 90% after 119 days. No microbial growth was observed. pH values remained fairly constant. The viscosity of the suspensions allowed easy re-dispersal of the drug particles upon shaking. This study demonstrates that clonidine hydrochloride is physically, chemically, and microbiologically stable in PCCA SuspendIt for 182 days in the refrigerator and for 119 days at room temperature at both concentrations studied, thus providing a viable, compoun

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease that may have profound effects on the patient's quality of life. A personalized HS combination therapy treatment was prescribed to a 54-year-old female suffering from multiple painful sores, as follows: naltrexone capsules titrated from 0.5 mg up to 4.5 mg; pentoxifylline 5%, rifampin 2%, clindamycin 1%, and glycolic acid topical cream. Clinical improvements were observed using two disease-specific outcome measures: Hurley Staging System and HS Score. The patient's HS improved from Stage II (moderate) to Stage I (mild), and the HS score decreased from 103 points with five anatomical regions reported, to 19 points with only three regions affected. Furthermore, the before and after treatment photographs showed a visible reduction in the number of boils/skin abscesses and an overall recovery. Improvements were also observed across all domains of the patient's self-reported quality of life (Hidradenitis Suppurativa Quality of Life Assessment). The patient did not experience any undesirable effects. Compounded medications may be customized to meet the patient's special needs and may be adjusted throughout the course of treatment to match the patient's individual progress. Although further studies are necessary, this personalized, combination therapy may be a key treatment option in HS.

This article represents the fourth in a series of articles on tips and hints of compounding. In this issue, we will discuss some tips and hints for the compounding of lollipops/lozenges, gummy bears, patches, flavoring/coloring, sweeteners, and packaging.

The author has been using ketamine to treat hospice patients for several years, with varying degrees of success, and reports being most successful with the transdermal-gel form. He has also had success with ketamine administered as a nasal spray. In addition to providing general comments on the use of ketamine in this context, he presents four brief case reports demonstrating the use of ketamine and other medications in treating pain associated with various types of cancer.