International journal of pharmaceutical compounding最新文献

Compounders worldwide are responsible for ensuring that the sterile preparations they dispense are pure, potent, and safe. To achieve that result, proper cleaning and disinfection of International Organization for Standardization controlled environments must occur. Because those tasks must be performed according to established standards, the compounding pharmacist must research regulatory requirements and appropriate products for use. In this report, we focus on U.S. regulations, guiding entities, and effective products that enable compliance with the increasingly stringent procedures required for pharmaceutical compounding. We also review cleaning and disinfecting processes, discuss the importance of correctly choosing and using disinfectants and/ or sporicidal disinfectants with surface claims in the cleanroom, and provide answers to questions frequently asked by staff who use those agents. In addition, we profile specific disinfectants that are compliant with United States Pharmacopeia Chapter <797> and current good manufacturing practice standards. Biological safety cabinets and compounding aseptic containment isolators must undergo an additional process that deactivates hazardous drug residues and removes them from the interior surfaces of those devices before they are cleaned and disinfected, but that discussion is beyond the scope of this article.

Male hypogonadism is a condition that is receiving increasing medical scrutiny, resulting in research producing results favorable to the consideration of maintaining physiological levels of testosterone. As healthcare professionals interested in the health and welfare of a significant portion of the population, surely compounding pharmacists are interested in what can be done for men with this condition to help these patients improve their quality of life and long-term health. This article discusses the various ways that men's testosterone levels can be raised and provides insight into the importance of androgen-estrogen balance.

Less than optimal thyroid effects can occur for many reasons, including lack of production, excessive binding, reduced conversion to the active form of thyroid, poor intracellular transport, poor receptor response, or autoimmune and toxicity issues. Differentiation of where the problem or problems causing the symptoms of hypothyroidism to occur is a key to the return to optimal thyroid response and successful treatment outcome. The concept of hypothyroidism, functional hypothyroidism, and functional hypometabolism as an alternative method to describe classical subclinical hypothyroidism symptoms according to the source of the malfunction are discussed in this article. The author also presents a unique method of using standard thyroid measurements to determine the areas of dysfunction and discusses the possible reasons for low production, excessive binding, poor conversion, and suboptimal receptor response. Appropriate treatment options for each area are discussed, including nutritional requirements. Thyroid replacement therapy options are presented and individualization of therapy based on need established with use of the thyroid gradient levels is discussed. Individualization of thyroid therapy will often require the use of compounded T3 or T4/T3 combination therapy. Compounding thyroid replacement allows for avoiding fillers that can interfere with absorption, unwanted diluents, unknown or nonstandardized ingredients from animal sources, providing more sustained action with less side effects, and individualizing the ratio of T4 and T3 initially, and as improvements are made in the patient's ability to convert T4 to T3.

Aspirin is a non-steroidal, anti-inflammatory drug used for a range of indications. For patients with aspirin hypersensitivities, a desensitization procedure may be prescribed, and the initial low doses of <81 mg need to be provided by compounded preparations. Compounding with aspirin is associated with stability challenges due to its poor chemical stability. Additionally, low-strength preparations often exhibit dosage accuracy and uniformity issues. This study was designed to assess the feasibility of compounding low-strength aspirin capsules for the use in desensitization protocols. Aspirin capsules of 40-mg, 10-mg, 3-mg, and 1-mg strengths were prepared by manual filling of dry powders. Formulations were kept as simple as possible for ease of compounding, and the ingredients and compounding procedures were carefully selected to minimize the moisture content and to optimize the dosage accuracy. For the 40-mg and 10-mg capsules, two formulations were tested, using pure drug or crushed tablet powder. For the 3-mg and 1-mg capsules, only one formulation was tested, using a 5% mixture of pure drug and cellulose. All formulations were filled into hydroxypropyl methylcellulose capsule shells and stored at room temperature for 90 days. A  stability indicating, high-performance liquid chromatography method was used to analyze the quality of the capsules. The initial potency results of all capsule formulations were within 100% to 105% of the label claim, and the standard deviation was <3% for all formulations except the 1-mg strength (7%). The use of crushed tablet powder over pure drug powder appeared to reduce the potency variability, probably due to the larger fill weight per capsule. Upon storage at room temperature, the 40-mg and 10-mg formulations retained >90% of the label claim for up to 90 days, but the 3-mg and 1-mg formulations retained >90% of the label claim for up to only 31 days. Low-strength aspirin capsules were prepared successfully by compounding with a beyond-use date of at least 31 days at room temperature. However, the overall trend confirmed the challenges of achieving dosage uniformity and aspirin stability at 3-mg and 1-mg strengths. For general application in compounding pharmacies, trial batches are recommended with proper analytical testing.

Why compound bioidentical hormones? Are there no similar commercial products? What is unique about the options compounding pharmacists offer compared with what is out in the marketplace? These are questions that physicians and other practitioners are asking, and it is very important that we have intelligent, well-thought answers when we respond. Times have changed, and the challenges we face today in marketing our compounded therapies are not the same as those of twenty years ago. Premarin is no longer at the top of the heap, and there are topical, commercial products that contain bioidentical estradiol, and capsules that contain the same progesterone that we use. Our compounding advantage comes from our abilities to prepare unique patient-specific products, and, very importantly, from our growing understanding of hormone receptors; we now know there are two main estrogen receptors, 1) estrogen receptor alpha and 2) estrogen receptor beta, and the growing knowledge base associated with the discovery of estrogen receptor beta is quite significant.

Obtaining estrogen balance with a physiologic estriol and estradiol ratio is an important aspect of physiologic bioidentical hormone restoration therapy. Risks, including that of breast cancer, should be minimized while attempting to obtain the protective benefits and symptom management with therapy. Estriol plays a central role in protecting against breast cancer and should be considered an integral part of therapy for any patient with lower than normal physiologic levels.

Maintaining the microbial quality of the environment is crucial in pharmaceutical institutions, especially community pharmacies, since they have a direct relationship with patients. The sterility of the environmental surfaces of pharmacies can be maintained by proper cleaning and disinfecting. Microbial contamination is the primary reason for product spoilage or deterioration. The present study was carried out to assess the sanitation practices of pharmacies on the maintenance of cleanliness followed by isolation and identification of microorganisms from surface and air samples of selected pharmacies. All the pharmacies followed daily sanitization practices in the pharmacy premises and surrounding environment. However, only 20% of the pharmacies cleaned their equipment daily. In total, 33 bacterial species were identified from the pharmacies. Of these, 31 were Gram-positive (29 coagulase-negative staphylococci) and 2 Streptococcus spp., while 2 were Gram-negative (Pseudomonas aeruginosa and Proteus vulgaris). The colony-forming unit count of air samples after one-hour exposure under uni-directional air flow was less than 20 except from one pharmacy which was 59. Significant statistical associations were not observed between the presence of separate extemporaneous preparation rooms, separate counseling places, type of disinfectant, spillage management, and the growth of organisms in the pharmaceutical products and complaints received for spoiled products. However, some pharmacies under investigation were confirmed to have had poor sterility-control practices since they showed the growth of fastidious organisms both Gram-negative bacilli and Gram-positive cocci of which the latter was in more abundance.

Onychomycosis is the most common fungal nail infection accounting for 50% of nail disorders. This infection is most common in the toenails than in the nails of the fingers. It is caused by various fungal species like Trichophyton rubrum, Trichophyton mentagrophytes, Scopulariopsis brevicaulis, Aspergillus spp, Fusarium spp, Acremonium spp, Alternaria spp, and Neoscytalidium. Among them, dermatophyte fungus is involved in 70% to 80% of infections. Clinically, there are five types of onychomycosis classified based on causative organism and location of infection origin. Diagnosis of this infection uses a mycological study of nail samples using multiple staining techniques like periodic acid-Schiff, calcofluor, Grocott methenamine silver, fluorescence, and microscopy. The major risk factors of this infection include diabetes mellitus, psoriasis, peripheral vascular diseases, obesity, metabolic syndrome, nail trauma, human immunodeficiency virus and/or acquired immunodeficiency syndrome, immune-compromised individuals, chronic kidney failure, athletic activity, smoking, and hyperlipidemia. The treatment options for onychomycosis include topical and systemic antifungal agents, nanoparticles, laser therapy, photodynamic therapy, and nail avulsion. This article describes several types of onychomycosis, symptoms, diagnosis, currently available therapy and its drawback, current research to rectify the issues, and future medicinal approaches to improve patient health.

Memantine hydrochloride is commonly prescribed for Alzheimer's disease and vascular dementia. However, the drug is only available in tablet form, a dosage form which is difficult for geriatrics to swallow. This problem is especially difficult for those patients diagnosed with Alzheimer's. This study was therefore aimed to develop and characterize an oral disintegrating film containing memantine hydrochloride using different types and concentrations of polymers. Using the solvent casting method, twelve formulations were developed, which involved manipulations on the type and concentration of the polymer. Afterwards, six formulations were selected to undergo characterization tests. These tests evaluated the films' tensile strength, Young's Modulus, percent elongation, folding endurance, disintegration and dissolution time, content uniformity, moisture loss, and moisture uptake. Polymers such as polyvinyl alcohol, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, and pullulan gum were respectively incorporated at different concentrations. The study found that only hydroxypropyl methylcellulose and polyvinyl alcohol formulations developed into acceptable oral disintegrating films. Formulation E (hydroxypropyl methylcellulose 50-mg/film), which exhibited optimal mechanical strength, fast disintegration and dissolution, and excellent content uniformity, was identified as the best formula. Although polyvinyl alcohol showed higher mechanical strength, hydroxypropyl methylcellulose films were better at fulfilling the optimal characteristics of an oral disintegrating film. The study showed that the mechanical strength increased proportionally to the polymer concentration in the polyvinyl alcohol film. However, for the hydroxypropyl methylcellulose film, the mechanical strength increased only when hydroxypropyl methylcellulose's concentration was increased from a 40-mg/film to a 50-mg/film but decreased with a 60-mg/film. To summarize, orally disintegrating films containing memantine hydrochloride was developed, characterized, and reasoned to have high potential to be marketed and to increase medication compliance among geriatrics suffering from Alzheimer's disease.