International journal of pharmaceutical compounding最新文献

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.

For the foreseeable future, timolol 0.5% nasal spray prepared by compounding pharmacists will be the only source for a potentially dramatic new paradigm in the treatment of acute migraine.1 It is also likely other medical conditions can be treated with the compounded timolol nasal spray that need extremely rapid therapeutic beta blocker blood levels when IV infusion is not possible or practical. This manuscript will review the research and development of compounded timolol medication over the past dozen years and reference previous articles in IJPC detailing how the pharmaceutical compounded product is prepared.2 A final goal is to engage physicians in a beneficial working relationship with compounding pharmacies to make immediately available to patients a nasal spray formulation of the beta blocker timolol 0.5% in solution. It has recently been demonstrated for the first time to benefit acute migraine treatment.

The individual physicochemical stabilities of Allopurinol, Clindamycin Hydrochloride, Naltrexone Hydrochloride, Spironolactone and Ursodiol in the proprietary suspending vehicle PCCA SuspendIt® have been previously studied and published by the author. Accordingly, Beyond-Use-Dates (BUDs) of 180 days were assigned to the five drugs based on the results of the respective studies. The data were donated to the United States Pharmacopeia (USP) for possible adoption as Official Compounded Drug Monographs. Following an extensive review process, all five studies were approved and published by the USP. However, due to a lack of microbiological stability information, the BUDs were limited to 90 days. The current study was undertaken as a follow-up project to determine the microbiological stability of these five drugs in PCCA SuspendIt® utilizing the same compounding procedures from the original studies. 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 goal was to provide a viable, compounded alternative for Allopurinol, Clindamycin Hydrochloride, Naltrexone Hydrochloride, Spironolactone and Ursodiol in a thixotropic liquid dosage form, with an extended BUD of 6 months to meet patient needs. Given that the physical and chemical stabilities of all five drugs have been previously established and adopted by the USP as official compounded monographs, additional microbiological stability data would allow the official BUDs in the USP to be extended to 180 days to conform to the physicochemical stabilities. The current study showed that the preservative system in PCCA SuspendIt® successfully protected all the suspensions from growth of challenge microorganisms per the USP Chapter <51> AME Test. The results of the current study combined with the previous physicochemical studies demonstrate the following: Allopurinol is physically, chemically and microbiologically stable in PCCA SuspendIt for 180 days in the refrigerator and at room temperature over a bracketed allopurinol concentration range of 10 - 20 mg/mL. Clindamycin Hydrochloride is physically, chemically and microbiologically stable in PCCA SuspendIt for 180 days in the refrigerator and at room temperature at a concentration of 10-mg/mL of clindamycin. Naltrexone Hydrochloride is physically, chemically and microbiologically stable in PCCA SuspendIt for 180 days in the refrigerator and at room temperature, over a bracketed naltrexone hydrochloride concentration range of 0.5 - 5.0 mg/mL. Spironolactone is physically, chemically and microbiologically stable in PCCA SuspendIt for 180 days in the refrigerator and at room temperature at a concentration of 5 mg/mL of spironolactone. Ursodiol is physically, chemically and microbiologically stable in PCCA SuspendIt for 180 days in the refrigerator and at room temperature, over a bracketed ursodiol concentration range of 50 -

Extemporaneously compounded Methimazole 1% and 10% in PLO Gel Mediflo™30 Pre-Mixed were studied to assess physical, chemical and microbial stability over time. The formulations were stored at room temperature in tightly closed, light resistant plastic containers. Chemical stability was evaluated using a validated, stability indicating HPLC analysis and physical stability was evaluated through observation of organoleptic appearance and pH measurement at predetermined time points. Lastly, antimicrobial effectiveness testing was conducted per USP <51> guidelines. The results indicate that compounded Methimazole remained within the stability criteria for the duration of the study and can be assigned an extended beyond-use-date of 120 days under the studied conditions.

From ancient times to the present, parasites and the diseases they transmit have jeopardized the health and wellbeing of working and companion canines worldwide. Many common pests that afflict dogs can be classified as ectoparasites (e.g., fleas, ticks, lice), which serve as vectors of pathogens transmitted as the organism feeds or defecates; or endoparasites (e. g, helminths, protozoa), which can cause slowly progressive subclinical canine diseases as well as acute illnesses associated with high morbidity and mortality rates. Safe, effective antiparasitic prophylaxis in dogs remains a topic of major interest to both veterinarians and their clients, especially with respect to the prevention of canine heartworm infection and flea or tick infestation. Many compounders, especially those whose pharmacy includes a retail component, counsel veterinarians and pet owners about preparations and commercially available medications that prevent or treat parasitic infestations and provide assistance in obtaining those therapies. To support such efforts, this article provides information about single agents and combination-drug products prophylactic against common canine parasites, emerging resistance to those medications, and the toxic effects that such treatments can engender in some canine breeds.

Amiloride is a U.S. Food and Drug Administration-approved diuretic agent used to treat hypertension and congestive heart failure. Recent human and animal studies have suggested that amiloride may also have a role in treating anxiety through its acid-sensing ion channel antagonism. Intranasal administration of amiloride nasal spray via an extemporaneously compounded preparation has the potential for rapid delivery to the site of action to achieve therapeutic outcomes in individual patients with anxiety disorders. However, these patient-specific preparations do not have the pre-formulation characterization, including chemical stability, that conventional manufactured dosage forms have. The objective of this study was to assess the estimated chemical stability of compounded amiloride nasal spray over 6 months and 12 months utilizing accelerated degradation with high heat and the Arrhenius equation. A stability-indicating highperformance liquid chromatography analytical method was employed at appropriate intervals over a 12-month period to reveal that amiloride remained chemically stable over the period tested and by extrapolation. Physical stability and compatibility with the preservative benzyl alcohol were also confirmed via visual inspection, pH monitoring, and measurement of turbidity.

Sterilization methods to produce sterile preparations include heat, gas, radiation, and filtration. This article focuses on heat, gas, and radiation sterilization, plus a brief introduction to bright-light sterilization. Microbiology basics and microbial death kinetics, key to understanding why these sterilization methods work, will also be briefly discussed. Filtration sterilization will be covered in a separate article.

Throughout recorded history, the canine-human connection has varied by custom, purpose, and intensity. In many cultures worldwide, dogs have long been considered essential workers, protectors and guardians, and, often, an integral part of the family unit. Ensuring the health and quality of life of those companion animals is essential to preserving the bond between dogs and their owners. Fortunately, advances in veterinary science continue to improve treatments and cures for and prophylaxis against a variety of deadly canine diseases, several of which can be sourced to ectoparasites or endoparasites. For many veterinary patients, a customized preparation often proves to be the best therapeutic option, but many compounding-pharmacy stores also include a retail component that offers ready access to manufactured prescription medications, including those prophylactic against canine flea, tick, or heartworm infestation. Because dog owners often need guidance in selecting such products and assistance with obtaining them, this article will be of special interest to ompounders in those pharmacies. To that end, the following content addresses common canine parasites and classes of drugs that prevent the illnesses they cause, with emphasis on heartworm disease.

Since ancient times, mouth fresheners in many different forms have been used throughout the world. Traditional knowledge describes the health benefits of mouth fresheners, and contemporary science is now investigating their benefits. Claims have been made that mouth fresheners not only improve digestion but also promote oral health. Similar, but in a more profound sense, probiotics offer astounding advantages in treating many disorders. In certain cases, probiotics also offer prophylactic effects. Numerous benefits for dental health are being studied for B. coagulans (MB-BCM9) and B. subtilis (MB-BSM12). In this current study, a probiotic and a mouth freshener were combined to ameliorate the impacts of both. The oral residence of probiotics was enhanced by employing mucoadhesive polymers. Numerous compositions were developed and evaluated for the unaltered growth of probiotics, along with other evaluations like microscopy, in vitro mucoadhesive strength, and stability studies. Xanthan gum and hydroxypropyl methylcellulose were used in the development of mucoadhesive probiotic powder by employing the lyophilization technique. More than five hours of residence time were observed in the in vitro study with goat oral mucosa. The enumeration study validated the label claims of MB-BCM9 and MB-BSM12. It also concluded that none of the components of the formulation had a detrimental effect on probiotics. In essence, the present work discloses the novel and stable formulation of a probiotic-based mouth freshener.