International journal of pharmaceutical compounding最新文献

Between warnings from the U.S. Food and Drug Administration and many articles being published with the consensus that testosterone-replacement therapy had an increased cardiovascular risks in men, thereby questioning the relative safety of the therapy, the needs of hypogonadal (low testosterone) men, who also present with symptoms related to this condition, are much less likely to receive a treatment that can significantly improve their quality of life. This article discusses a major research project that determined that testosterone replacement therapy was no worse than a placebo in men with cardiovascular disease or at high risk for cardiovascular disease.

The most common reason for metformin incompliance is due to its side-effect profile. Metformin can cause issues with the gastrointestinal tract and result in nausea, abdominal pain, diarrhea, bloating, or vomiting. The size of the metformin tablet, which is quite large, is another reason for incompliance. Compounding pharmacists can prepare a topical formulation of metformin, which helps eliminate the unwanted gastrointestinal side effects, as well as eliminate the incompliance due to the size of the tablet. The transdermal use of metformin also allows the patient to take a much lower dosage compared to oral metformin. An oral liquid formulation can also help resolve the issue of swallowing a large tablet for those patients who are diagnosed with dysphagia.

Pharmaceutical foams are gaining in popularity. The use of foam technology now delivers a range of topical active agents, including corticosteroids, other anti-inflammatories, sunscreen compounds, and antibacterial, antifungal, and antiviral agents. In addition to the distinct application advantages and improved patient compliance with foams, a real reason for the rapid growth of topical foam technology is that foams are elegant and aesthetically and cosmetically appealing products that provide an alternative to ointments, creams, lotions, and gels in the highly competitive dermatological market. In addition to all this, foams can be easily compounded for patients to take advantage of the uniqueness and applicability of this dosage form in medication administration. As an example, for the treatment of inflamed skin conditions such as sunburn and eczema, topical foams are preferred because they can be spread more easily and thereby minimize the amount of rubbing required to distribute the formulations. Another innovative use of forms is in administering a liquid medication to a bedridden patient. When a liquid is placed in a spoon or measuring device, it may spill. However, if the foam is placed in the spoon, it can be delivered to the patient without spilling. Properly formulated, this foam can be spill resistant, reproducible, easily flavored and taste masked, and pediatric and geriatric friendly.

The effects of infection with the highly transmissible severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the coronavirus- disease-2019 (COVID-19) it engenders continue to demonstrate that worldwide, the detection, prediction, and control of novel-pathogen pandemics remain largely unattained achievements. Key to successfully meeting those goals is a thorough understanding of the mechanisms of evolving causative agents and effective prophylaxis against them. In this article, we review common conditions that afflict people with COVID-19 or long COVID, examine the effectiveness of vaccines designed to prevent infection with SARS-CoV-2 and mitigate its sequelae, and provide formulations for 2 compounded preparations that can assist recovery from acute and chronic conditions caused by that virus when manufactured drugs are unavailable in required dosages or dosage forms or cannot be tolerated by the patient.

To evaluate the transdermal delivery of six analgesic drugs (i.e., ketamine, gabapentin, clonidine, lidocaine, ketoprofen, and amitriptyline) that were compounded into three commercially available bases, Salt Stable LS Base, Transdermal Pain Base, and Lipoderm ActiveMax Base, the Franz finite dose model was used for an in vitro penetration study using porcine skin over 48 hours. Rapid penetration with a steady-state flux after the first 24 hours was detected in all the formulations. The present study demonstrates the successful delivery of six compounded analgesic drugs, using all of the noted bases. A high flux rate within 1 hour to 4 hours of application would correlate to effective pain relief, and the prolonged delivery over the first 24 hours would reduce the need for frequent reapplication. This can aid in pain management with the potential for enhanced pain control.

This study aimed to develop controlled-release matrix tablets of naproxen using the hydrophilic polymer sodium carboxymethylcellulose, investigate the impact of surfactants and other excipients on drug release and swelling rate, and determine the drug release mechanism. Naproxen matrices were formulated by the direct compression technique with different ratios of polymer sodium carboxymethylcellulose and other excipients. Drug release, swelling behavior, and release mechanism were assessed using an acidic dissolution medium. Drug release rate and mechanism were characterized by fitting the zero-order, first-order, Higuchi, and Korsmeyer-Peppas models. The amount of polymer sodium carboxymethylcellulose and other additives significantly affected drug release by regulating its rate according to polymer sodium carboxymethylcellulose ratios. Surfactants increased the drug release based on their solubility and wetting effects, independent of their charges. The release mechanism involved a combination of polymer diffusion and tablet erosion during dissolution. This study demonstrated that controlled release matrix tablets of naproxen can be effectively prepared by incorporating polymer sodium carboxymethylcellulose and other excipients via direct compression. The quantity of excipients can be adjusted to control the drug release rate from the matrices. The dissolution medium and the surfactants did not affect the matrix swelling, while the surfactants increased drug release via solubility and wetting effects rather than their charge. These findings have important implications for the design and development of controlled-release drug delivery systems.

This article, which is part 1 of a series on compounding with antioxidants, discusses specific preparation methods and techniques along with packaging, storing, and labeling issues. Also presented are the allowable overages from the United States Pharmacopeia's discussion on "Commercial Parenteral Products". Some considerations related to potential issues when compounding with commercial products are also discussed using specific examples. The article ends with a discussion of product standardization and look-alike products. The formulation of an antioxidant system is accomplished primarily through trial and error. With some experimentation and patience, a suitable, stable system with the required characteristics can be obtained.

Studies have evaluated epinephrine stability in higher concentrations and shorter durations than we require. The objective of this study was to evaluate the chemical stability of epinephrine in syringes at concentrations of 10 mcg/mL in 0.9% sodium chloride at 4°C and 25°C. Solutions of 10 mcg/mL epinephrine in 0.9% sodium chloride were prepared and stored in 10-mL Becton, Dickinson and Company syringes. Three units of each container were stored at 4°C and 25°C. Concentration analysis was completed on study days 0, 2, 7, 14, 21, 28, 42, 56, 72, and 91 using a validated stability-indicating liquid chromatographic method with ultraviolet detection. Chemical stability was based on the intersection of the lower limit of the 95% confidence interval of the observed degradation rate and the time to achieve 90% of the initial concentration (T-90). The analytical method separated degradation products from epinephrine to measure concentration specifically, accurately, and reproducibly. During the study period, all solutions at 4°C retained more than 89.62% of the initial concentration for 91 days. Solutions stored at 25°C retained more than 90% for 21 days. Multiple linear regression revealed significant differences in percent remaining due to study day (P<0.001) and temperature (P=0.002). The calculated T-90, with 95% confidence, was 71.40 days for solutions stored at 4°C but only 12.77 days for solutions stored at 25°C. We conclude that 10 mcg/mL epinephrine solution diluted in 0.9% sodium chloride stored at 4°C is chemically and physically stable for 64 days, with 95% confidence. The syringe may be held at room temperature for up to 24 hours during this period and still retain more than 90% of the initial concentration.

Azathioprine is used to treat the symptoms of rheumatoid arthritis and for the prevention of transplant rejection. A review of the therapeutic uses of Azathioprine 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 Azathioprine currently exists. Azathioprine is commercially available only as a 50-mg tablet. 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 Azathioprine 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 Azathioprine 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 Azathioprine in PCCA SuspendIt was developed and validated. Suspensions of Azathioprine were prepared in PCCA SuspendIt at 10-mg/mL and 50-mg/mL concentrations, selected to represent a range within which the drug is commonly dosed. 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, 49, 63, 90, 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. The study showed that Azathioprine concentrations did not go below 96.8% of the label claim (initial drug concentration) at both temperatures studied. No microbial growth was observed. The pH values remained constant. The viscosity of the suspensions allowed easy re-dispersal of the drug particles upon shaking. This study demonstrates that Azathioprine is physically, chemically, and microbiologically stable in PCCA SuspendIt for 182 days in the refrigerator and at room temperature, thus providing a viable, compounded alternative for Azathioprine in a liquid dosage form, with an extended beyond-use date to meet patient needs.