IntroductionWounding affects the integrity of the skin and can ultimately result in skin scarring. Current therapeutic goals of wound treatment focus on the reduction of scar formation and severity. However, scar formation itself varies not only between individuals based on factors such as ethnicity, but also within an individual based on the location of the wound. Therefore, the preparation of customized treatments for individual patients represents an important therapeutic goal in the fields of dermatology and wound healing. The objective of this study was to evaluate the usefulness of fatty acids found in pracaxi oil in a compounded topical anhydrous silicone base for wound and scar therapy.MethodsInitially, 21 patients with various surgical, traumatic, or burn wounds and scars were enrolled into this case series. Patients applied a compounded topical anhydrous silicone base containing pracaxi oil with or without additional active ingredients, including pentoxifylline, caffeine, tranilast, and mupirocin. Wound/scar photographs taken before and after application of the compounded pracaxi oil topical formulation (with/without additional ingredients) were reviewed and adjudicated by a blinded dermatology reviewer. Improvements in wound size, coloration, and overall appearance before and after treatment were determined. Patient satisfaction was assessed after application of compounded topical formulation using a self-report questionnaire distributed at the time of dispensing.ResultsA total of seven patients were considered available for analysis and were included in the study. In all seven cases, patients reported improvement in scar and wound attributes, including scar and wound size, severity, color, and pain associated with the scar or wound after application of the compounded medicine. On average, patients rated their satisfaction with treatment highly, with a mean score of 10 on a rating scale of 1–10. Retrospective review of wound/scar photographs demonstrated clinically relevant improvements in wound attributes as assessed by a dermatologist. Six of the seven wounds examined were considered “much improved” from baseline.ConclusionsApplication of a compounded anhydrous silicone base containing pracaxi oil alone or in combination with other active substances led to considerable improvements in wound healing and scar attributes and is a potentially useful option in the treatment of surgical, traumatic, or burn wounds and scars.Electronic supplementary materialThe online version of this article (doi:10.1007/s13555-014-0065-y) contains supplementary material, which is available to authorized users.
This study suggests that the combination of these 4 analgesic drugs can be successfully delivered transdermally, using either Lipoderm or Lipoderm ActiveMax. Compounded transdermal drug preparations may then provide physicians with an alternative to traditional oral pain management regimens that can be personalized to the specific patient with the potential for enhanced pain control.
Objectives:The treatment of diabetic ulceration of the lower extremities is a complicated task due to the nature of the ulcer and potential underlying comorbidities. This report describes the case of a 61-year-old male patient with Type 2 Diabetes who presented with an ulcerative leg wound. The objective of this study was to evaluate the outcome of a topical compounded treatment.Methods:The patient applied a compounded medicine containing 2% mupirocin in a topical anhydrous silicone base containing fatty acids from pracaxi oil directly to the ulcer for 63 days, 3 times daily. This regimen was supplemented with exercise and an additional compounded medicine applied to the wound margins in order to increase circulation.Results:By the end of the application period, the patient’s ulcer was fully closed.Conclusion:A topical anhydrous silicone compounding base containing fatty acids from pracaxi oil may be useful in the treatment of patients with diabetic ulcers.
Importance: More information is needed about the efficacy and safety of compounded bioidentical hormone therapy (cBHT) in the published literature. A thorough synthesis of existing data is not currently available.Objective: To provide a systematic review and meta-analysis of the existing evidence related to the safety and efficacy of commonly prescribed cBHT preparations in perimenopausal and postmenopausal women.Evidence Review: PubMed, ClinicalTrials.gov, and The Cochrane Central Register of Controlled Trials were searched. Randomized controlled trials (RCTs) comparing cBHT with a placebo or FDA-approved products in perimenopausal or postmenopausal women were eligible. The risk of bias was assessed by the Cochrane risk of bias tool. The primary safety outcome was changes in lipid profile and glucose metabolism, and the primary efficacy outcome was the change of vaginal atrophy symptoms. The secondary outcomes included the change of endometrial thickness, risk of adverse events, vasomotor symptoms, change of serum hormone levels, and change of bone mineral density.Findings: A total of 29 RCTs reported in 40 articles containing 1,808 perimenopausal and postmenopausal women were included. Two risk factors of cardiovascular disease, lipid profile, and glucose metabolism, were evaluated with cBHT. The results showed that compounded androgen was not associated with change of lipid profile or glucose metabolism. There was no change in endometrial thickness or serious adverse events. There were more androgenic side effects with compounded dehydroepiandrosterone compared with placebo as expected. Other safety measures including clinical cardiovascular events, endometrial biopsy, and risk of breast cancer were not studied. cBHT in the form of compounded vaginal androgen was found to significantly improve vaginal atrophy symptoms (SMD À0.66 [95% CI, À1.28 to À0.04]; I 2 ¼ 86.70%). This finding was supported by the association between compounded vaginal androgen and improved female sexual function scores. The changes of serum hormone levels were also evaluated. Despite the variations in absorption from different types of compounded hormones, routes, and strengths, the trends were consistent with published data from FDA-approved products.Conclusions and Relevance: This review found that cBHT used in primarily short-term RCTs is not associated with adverse changes in lipid profile or glucose metabolism. cBHT in the form of vaginal androgens appears beneficial for vaginal atrophy symptoms. There are insufficient RCTs of cBHT to assess clinical risk of breast cancer, endometrial cancer, or cardiovascular disease. Long-term studies with clinical endpoints are needed.
The efficacy of active pharmaceutical ingredients (API) in compounded medications for oral mucosa greatly depends on the composition of the base. Here, we assessed the safety, facilitation of cell migration, and mucoadhesive properties of a newly developed mucoadhesive polymer blend (MPB) which contains pullulan, tamarindus indica polysaccharide, and sodium hyaluronate. No cell death was observed when human oral keratinocyte (HOK) and fibroblast (HOrF) cells were exposed to 1% MPB for 24 h. Epithelial cells in a 3D buccal tissue model (EpiOral) were unaffected when exposed to 50% MPB for 20 h whereas 1% Triton X-100 killed 93% cells after 4.5 h. The expressions of cytokines IL1α and IL1β and cell proliferation markers PCNA, CYCLIN A, and CYCLIN D1 in EpiOral tissue did not increase suggesting that MPB is neither an irritant nor a mitogen. Markers of apoptosis such as cleavage of CASPASES 8/9, upregulation of pro-apoptosis NOXA protein, and downregulation of anti-apoptosis XIAP protein were observed in Triton X-100-treated cells but not in cells exposed to MPB. The migration of HOK and HOrF cells was stimulated by MPB, and the expression of E-CADHERIN in the EpiOral tissues was unaffected. Moreover, MPB showed stronger mucoadhesion on the human EpiOral tissue model compared with a reference product. We conclude that MPB can safely deliver API within the oral mucosa, facilitate cell migration, and may increase drug efficacy through its strong mucoadhesive property.
Capsules are the most popular and versatile dosage form produced in pharmaceutical compounding. In the preparations of capsules, powder excipients are non-active ingredients that can be used for the purpose of increasing bulk, enhancing flow, and improving stability of a powder formulation. Flow properties of powder excipients can impact not only the compounding procedure, but also the uniformity and quality of the final product. In this study, an FT4 powder rheometer was used to compare dynamic, bulk, and shear properties of the following four powder excipients: Loxoral, Loxasperse, a commercial powder excipient, and lactose Downloaded by [RMIT University] at 23:57 17 August 2015 2 monohydrate. Changes in flow energy, measured as the powders are exposed to external conditions such as air, compression, consolidation, and shear forces were used to compare flow properties of the four excipients. Results show Loxasperse to have superior dynamic properties, indicating more efficient packing potentials. Though Loxoral did not have the most favorable flow in terms of dynamic properties, Loxoral outranked the other excipients when comparing bulk and shear properties. Taking into account processing equipment and the external environment, compounding pharmacists can reevaluate current formulas to include excipients with more favorable flow properties, resulting in more uniform and higher quality products.
Chronic musculoskeletal pain can be a major burden for most patients, affecting their lifestyle and reducing overall quality of life. When compared to PLO, phospholipid base has the ability to potentially deliver higher concentrations of ketoprofen to underlying soft tissues and at a more rapid rate. With more ketoprofen at the site of injury, the analgesic and anti-inflammatory effects will likely be enhanced, potentially reducing pain and improving quality of life.
There is a lack of an age-appropriate formulation of fluconazole. The extemporaneous preparation of an oral suspension with an extended beyond-use-date may represent a good therapeutic alternative for the paediatric population. A fluconazole 50 mg/mL oral suspension was prepared and evenly distributed into twenty amber plastic bottles: ten bottles were stored in controlled room temperature (25⁰C) whereas the remainder ten bottles were stored in refrigerated temperature (5⁰C). The physical characteristics (colour/appearance, odor, pH and density) and chemical characteristics [fluconazole concentration using Ultra High Performance Liquid Chromatography (UPLC)] of the oral suspension were tested at nine pre-determined time-points over a period of 182 days. The density, pH and mean concentration of the oral suspension did not change significantly. The recovery of fluconazole ranged from 92.67 % to 98.79 % (5⁰C) and from 94.31 % to 100.02 % (25⁰C), both within the specification limits. A palatable, sugar-free formula was developed for fluconazole 50 mg/mL in the oral suspending vehicle SuspendIt™ to allow an easy and rapid extemporaneous preparation in the hospital setting. The beyond-use-date of the formula was determined using a valid, stability-indicating analytical method and it was concluded that the extemporaneously prepared oral suspension is stable for 6 months at refrigerated and controlled room temperature.
There is a lack of an age-appropriate formulation of fluconazole. The extemporaneous preparation of an oral suspension with an extended beyond-use-date may represent a good therapeutic alternative for the paediatric population.
A fluconazole 50 mg/mL oral suspension was prepared and evenly distributed into twenty amber plastic bottles: ten bottles were stored in controlled room temperature (25⁰C) whereas the remainder ten bottles were stored in refrigerated temperature (5⁰C). The physical characteristics (colour/appearance, odor, pH and density) and chemical characteristics [fluconazole concentration using Ultra High Performance Liquid Chromatography (UPLC)] of the oral suspension were tested at nine pre-determined time-points over a period of 182 days.
The density, pH and mean concentration of the oral suspension did not change significantly. The recovery of fluconazole ranged from 92.67 % to 98.79 % (5⁰C) and from 94.31 % to 100.02 % (25⁰C), both within the specification limits.
A palatable, sugar-free formula was developed for fluconazole 50 mg/mL in the oral suspending vehicle SuspendIt™ to allow an easy and rapid extemporaneous preparation in the hospital setting. The beyond-use-date of the formula was determined using a valid, stability-indicating analytical method and it was concluded that the extemporaneously prepared oral suspension is stable for 6 months at refrigerated and controlled room temperature.
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