International journal of pharmaceutical compounding最新文献

Objective: The objective of this study was to determine the physicochemical and microbiological stability of a 0.5% aqueous oral solution of methadone for dispensing to Drug Dependency Centers in the Region of Murcia.

Materials and methods: Six different batches of 5 L methadone 0.5% solution were prepared in purified water. The samples were stored at controlled room temperature (<30°C), three protected from light and three not protected from light. Physicochemical analysis (concentration and pH) and microbiological analysis were performed on days 0, 15, 30, and 60 after preparation.

Results: The average concentration variation for samples protected from light was 98.4 (RSD 0.01%), and 100.97 (RSD 0.003%) for those not protected from light. pH values remained <6.5 throughout the study, increasing slightly over time. Organoleptic characteristics remained unchanged during the study period. Microbial growth was not observed in any of the samples analyzed, meeting acceptance criteria for oral liquid magistral formulations.

Conclusion: The 0.5% methadone solution showed chemical, physical, and microbiological stability for 60 days after preparation. These results have allowed extending the expiration date of the preparation and optimizing the dispensing circuit of methadone to Drug Dependency Centers.

Fast Melt Tablet (FMT) is a newer type of orally disintegrating tablet using the advantage of cocoa butter that melts at body temperature to achieve fast melting effect when the tablet is placed in oral cavity. However, oral disintegrating dosage form must have good palatability so that patients can accept it. The objective of this study is to taste mask a previously developed FMT containing memantine hydrochloride using artificial sweetener namely aspartame and acesulfame K and conduct a palatability study. Six formulations were developed and each sweetener was used at three level (10mg, 20mg and 30mg) to taste mask memantine hydrochloride in FMT. Formulation T7 was selected as the best taste masked formulation. Aspartame 30mg is sufficient to cover the bitter taste of memantine hydrochloride. A taste masked memantine hydrochloride FMT containing 30mg of aspartame was successfully developed. This formulation has hardness of 17.31 (0.18) Newton, 0.51 (0.02) g weight, 6.18 (0.42) mm thickness and in-vitro melting time of 31.16 (1.23) seconds. This novel dosage form has the potential to be commercialized as a patient friendly dosage form to treat Alzheimer's disease.

Topical preparations represent a large percentage of compounded prescriptions, particularly in the area of dermatology. Properties of ointment bases vary greatly, and active ingredients are frequently added as aqueous or alcoholic solutions. Currently, there are no quantitative guidelines stating the various water and alcohol absorption capacity of different bases. A short experiment was designed to quantitate the amount of water or alcohol that could be absorbed by a series of ointment bases of varying types. Our findings may be used to assist compounding pharmacists in deciding what base is most suitable to use when considering the amount of water, alcohol, or any similar solvent needed to compound the preparation. A general overview of issues related to topical medication compounding is also provided in this article.

Topical treatment of burn wounds in all stages of burns plays an important role in the course and outcome of the acute period of burn injury, the patient's recovery time, and the development of infectious complications. Curcumin is considered a promising raw material in dermatology practice due to its accelerated wound-healing properties. However, as a result of the studies, it became clear that curcumin-based topical gel drug form for the treatment of burns has not been developed. In this study, we developed a new composition of the gel form for the treatment of burn wounds and its qualitative parameters were identified by Raman spectroscopy. A series of curcumin-containing gel formulations were prepared and evaluated based on their consistency, homogeneity, stability, and curcumin concentration, with the objective of identifying the optimal formulation. Drug kinetics were studied using diffusion methods. It has been demonstrated that a stable and pharmacologically active gel containing curcumin can be created, which has the potential for use in the clinical treatment of burn wounds.

Pharmaceutical compounding is the art and science of preparing customized medications to meet the specific and unique needs of patients. To compound preparations that are safe, effective, and of the highest quality, it is vital that pharmacists are knowledgeable regarding current guidelines and standards and able to demonstrate competency in compounding skills. While various instructional methods have been utilized within pharmacy education to train students on such skills, one strategy that has not been extensively studied is peer-assisted learning. This commentary aims to discuss strategies for employing peer-assisted learning-including peer teaching and near-peer teaching-within compounding courses, highlight the benefits and challenges of this instructional strategy, and put forth a call to action for additional research into the design, implementation, and outcomes associated with the use of peer-assisted learning in compounding education.

Objective: In pediatrics, weight-based doses can be very small, leading to measuring tiny volumes of the commercial desmopressin nasal solution at 0.1mg/mL, which reduces precision and increases the risk of error. Since stability of the desmopressin acetate solution diluted at 0.01 mg/mL has not been properly demonstrated, the aim of this study was to demonstrate its 180 days physicochemical stability when stored in clear glass vials at 5°C and 25°C. Glass vials are used for their simplicity and user-friendliness.

Methods: The desmopressin acetate solutions were prepared by diluting a commercial nasal spray (0.1 mg/mL) with 0.9% sodium chloride to achieve a concentration of 0.01 mg/mL and aliquoted in clear glass vials. Stability study encompassed the samples being subjected to incubation at 5 ± 2°C and 25 ± 2°C/60 ± 5% RH for up to 180 days. Evaluation at specific intervals involved withdrawal of 1 mL aliquots for inspection of organoleptic properties and desmopressin acetate concentration assays using the HPLC-UV method. The particle count analysis was also performed on freshly prepared solutions at the initial time point and at the end of the study. The necessary microbiological tests were also carried out.

Results: The HPLC-UV method for desmopressin acetate quantification demonstrated robustness and low intraday variability (r2 = 0.999, highest RSD 0.40%). Stability studies over 180 days revealed no notable changes in odor and color, with consistent assay results and particle count evaluation meeting USP <788> criteria. No bacterial growth was noted.

Conclusion: Desmopressin acetate prepared at 0.01 mg/mL from commercial nasal solutions using 0.9% sodium chloride when stored in clear glass vials at 5°C and 25°C remained stable for up to 180 days.

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.

Objective: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.