Physicochemical and Microbiological Stability of Compounded Bethanechol Chloride Oral Suspensions in PCCA Base, SuspendIt®.

Bethanechol chloride is a cholinergic agent used to treat acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. It is available in the United States as tablets for oral administration in four dosage strengths: 5 mg, 10 mg, 25 mg, and 50 mg. A review of the therapeutic uses of bethanechol chloride 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 bethanechol chloride currently exists. An extemporaneously compounded suspension from pure drug powder or commercial tablets 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 bethanechol chloride suspensions using two brands of commercially available tablets (Amneal and Upsher-Smith) 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 bethanechol chloride concentrations to provide stability documentation over a bracketed concentration range for eventual use by compounding pharmacists. A robust stability-indicating ultra-high-performance liquid chromatographic assay for the determination of the chemical stability of bethanechol chloride in PCCA SuspendIt was validated. Suspensions of bethanechol chloride were prepared from the tablets in PCCA SuspendIt at 1-mg/mL and 5-mg/mL concentrations, selected to represent a range within which the drug is commonly dosed. Samples were stored in amber plastic prescription bottles at room temperature (25°C). Samples were assayed initially, and on the following time points (days): 14, 30, 60, 90, and 180. Physical data such as pH and appearance were also noted. Microbiological stability was tested. 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. Using this criterion, no significant degradation of the bethanechol chloride was observed over the 180-day test period for either concentration at room temperature. Drug concentrations were at, or above 93% of initial values for both brands of commercially available tablets. No microbial growth was observed. pH values remained fairly constant. This study demonstrates that bethanechol chloride tablets are physically, chemically, and microbiologically stable in PCCA SuspendIt for 180 days at room temperature at both concentrations studied, thus providing a viable, compounded alternative for bethanechol chloride in a liquid dosage form, with an extended BUD to meet patient needs.

Integrated In Vivo and In Vitro Evaluation of a Powder-to-Hydrogel, Film-Forming Polymer Complex Base with Tissue-Protective and Microbiome-Supportive Properties.

The study aimed to perform a comprehensive in vitro and in vivo evaluation of a newly developed, patent-pending, powder-to-hydrogel, film-forming polymer complex base, which possesses tissue-protective and microbiome-supportive properties, and to compare its characteristics with poloxamer 407. The study used a combination of in vitro assays, including tissue viability and cell migration, and in vivo wound healing evaluations in male diabetic mice. Microbiome dynamics at wound sites were also analyzed. The in vitro assays demonstrated that the polymer complex base was non-cytotoxic and that it enhanced cell migration over poloxamer 407. In vivo, the polymer complex base demonstrated superior wound healing capabilities, particularly in combination with misoprostol and phenytoin, as evidenced by the reduced wound area and inflammation scores. Microbiome analysis revealed favorable shifts in bacterial populations associated with the polymer complex base-treated wounds. The polymer complex base demonstrates clinical significance in wound care, potentially offering improved healing, safety and microbiome support. Its transformative properties and efficacy in drug delivery make it a promising candidate for advanced wound care applications, particularly in chronic wound management.

Testosterone Therapy for Late-Onset Hypogonadism: A Clinical, Biological, and Analytical Approach Using Compounded Testosterone 0.5-20% Topical Gels.

Testosterone is integral to men's sexual and overall health, but there is a gradual decline in the ageing male. The topical administration of testosterone is a valuable option as a supplement (replacement) therapy to alleviate hypogonadal symptoms. The clinical efficacy of a compounded testosterone 5% topical gel was assessed retrospectively in a male patient in his seventies by evaluating the laboratory testing of the serum total testosterone and the results of a validated androgen deficiency questionnaire. After treatment, the patient's hypogonadal symptoms improved and the serum total testosterone level achieved was considered clinically optimal. The skin permeation of the testosterone topical gel (biological testing) was evaluated in vitro using the Franz finite dose model and human cadaver skin, and it is shown that testosterone can penetrate into and through ex vivo human skin. Testosterone therapy is often prescribed for extended periods, and consequently, it is crucial to determine the beyond-use date of the compounded formulations. The analytical testing involved a valid, stability-indicating assay method for compounded testosterone 0.5% and 20% topical gels. This multidisciplinary study shows evidence supporting topically applied testosterone's clinical efficacy and the compounded formulations' extended stability. Personalized, topical testosterone therapy is a promising alternative in current therapeutics for hypogonadal patients.

In vitro evaluation of the percutaneous absorption of progesterone in anhydrous permeation-enhancing base using the Franz skin finite dose model and mass spectrometry.

Progesterone is used for hormone replacement therapy through various routes of administration. This study was conducted to (a) evaluate the stability of progesterone in a proprietary anhydrous permeation-enhancing base (APEB) and the efficiency of its skin permeation, and (b) determine the appropriateness of mass spectrometry as a method of analysis for permeated progesterone. Using a proven stability-indicating ultra-performance liquid chromatographic method, the compounded hormone (100 mg progesterone/g APEB gel) was determined to be physically and chemically stable at room temperature for six months. Skin permeation analysis using the Franz skin finite dose model and mass spectrometry imaging showed an optical density of 1699 for the permeated progesterone compounded in APEB and 550 for the permeated progesterone in a water containing VBC, which is a statistically significant different (P = 0.029). The study suggests that APEB can be used as a compounding base for effective skin permeation of progesterone, and mass spectrometry is a reliable method for visualization and quantitative analysis of permeated progesterone.

Evaluation of a compounding phospholipid base for the percutaneous absorption of high molecular weight drugs using the Franz finite dose model.

BACKGROUND: Permeation-enhancing compounding bases are aimed to facilitate the penetration of the active pharmaceutical ingredients (APIs) across the skin barrier. OBJECTIVES: The purpose of this study was to evaluate the percutaneous absorption of radiolabeled human insulin (14 C-isototpe) when incorporated in a proprietary phospholipid base designed to deliver APIs with high molecular weights (HMW). The aim was not to claim the transdermal delivery of insulin with potential therapeutic applications in diabetes but, instead, to evaluate the ability of the compounding phospholipid base to deliver HMW drugs. METHODS: The percutaneous absorption of 14 C-insulin was determined using human torso skin and the Franz skin finite dose model. Two topical test formulations were prepared for in vitro evaluation: insulin 1% in phospholipid base (standard) and insulin 1% in phospholipid base HMW. The rate of percutaneous absorption (mean flux) and the distribution of 14 C-insulin through the skin were evaluated for both topical test formulations. A two-way ANOVA was used to determine statistical differences. RESULTS: The 14 C-insulin was distributed into the stratum corneum, epidermis and dermis. Mean flux values showed a rapid penetration upon application and the maximum flux was achieved at 30 min, followed by a slow decline. Subsequently, a slower decline was observed for the topical test formulation including the phospholipid base HMW. CONCLUSION: The phospholipid base HMW facilitates the percutaneous absorption of HMW drugs across human cadaver skin and, therefore, it may potentially be a useful option for compounding pharmacists and practitioners when considering the skin for the percutaneous delivery of large drugs.

Cutaneous targets for topical pain medications in patients with neuropathic pain: individual differential expression of biomarkers supports the need for personalized medicine.

Introduction: Numerous potential cutaneous targets exist for treating chronic pain with topically applied active pharmaceutical ingredients. This preliminary human skin tissue investigation was undertaken to characterize several key biomarkers in keratinocytes and provide proof-of-principle data to support clinical development of topical compounded formulations for peripheral neuropathic pain syndromes, such as postherpetic neuralgia (PHN). Objectives: The study intended to identify objective biomarkers in PHN skin on a patient-by-patient personalized medicine platform. The totality of biopsy biomarker data can provide a tissue basis for directing individualized compounded topical preparations to optimize treatment efficacy. Methods: Referencing 5 of the most common actives used in topical pain relief formulations (ketamine, gabapentin, clonidine, baclofen, and lidocaine), and 3 well-established cutaneous mediators (ie, neuropeptides, cannabinoids, and vanilloids), comprehensive immunolabeling was used to quantify receptor biomarkers in skin biopsy samples taken from ipsilateral (pain) and contralateral (nonpain) dermatomes of patients with PHN. Results: Epidermal keratinocyte labeling patterns were significantly different among the cohort for each biomarker, consistent with potential mechanisms of action among keratinocytes. Importantly, the total biomarker panel indicates that the enriched PHN cohort contains distinct subgroups. Conclusion: The heterogeneity of the cohort differences may explain studies that have not shown statistical group benefit from topically administered compounded therapies. Rather, the essential need for individual tissue biomarker evaluations is evident, particularly as a means to direct a more accurately targeted topical personalized medicine approach and generate positive clinical results.

Evaluation of the in vitro human skin percutaneous absorption of ketoprofen in topical anhydrous and aqueous gels.

BACKGROUND: Ketoprofen is a nonsteroidal anti-inflammatory drug used for the treatment of acute and chronic pain associated with inflammatory conditions. This study aims to evaluate the in vitro percutaneous absorption of ketoprofen 10% formulated in proprietary anhydrous and aqueous gels using the Franz skin finite dose model. MATERIALS AND METHODS: The anhydrous gel was initially characterized for cytotoxicity using EpiDerm skin tissue model by cell proliferation assay and Western blot analysis. The Ultra Performance Liquid Chromatography method for measuring ketoprofen was validated and the stability of ketoprofen 10% in the anhydrous gel formulation was evaluated at 5°C and 25°C for 181 days. The percutaneous absorption of ketoprofen was determined using donated human skin. The tissue sections were mounted within Franz diffusion cells. A variable finite dose of each ketoprofen formulation in either anhydrous or aqueous gel was applied to the skin sections and receptor solutions were collected at various time points. RESULTS: Cell proliferation assay showed minimal cell death when EpiDerm skin tissue was exposed to the anhydrous gel for 24 h; the levels of protein markers of cell proliferation were not affected after 17-h exposure. Ketoprofen was stable in the anhydrous gel when stored at 5°C and 25°C. When compounded in the anhydrous and aqueous gels, ketoprofen had mean flux rate of 2.22 and 2.50 µg/cm2 /h, respectively, after 48 h. The drug was distributed to the epidermis and dermis sections of the skin. Both the anhydrous and aqueous gels facilitated the percutaneous absorption of ketoprofen without statistically significant differences. CONCLUSION: The anhydrous gel can be used as a base to facilitate the transdermal delivery of ketoprofen. Although the anhydrous and aqueous gels can deliver a similar amount of ketoprofen, the anhydrous gel (water activity below 0.6) allows for extended default beyond-use-date of compounding preparations.

Analysis of the Physical Characteristics of an Anhydrous Vehicle for Compounded Pediatric Oral Liquids.

The paucity of suitable drug formulations for pediatric patients generates a need for customized, compounded medications. This research study was set out to comprehensively analyze the physical properties of the new, proprietary anhydrous oral vehicle SuspendIt® Anhydrous, which was designed for compounding pediatric oral liquids. A wide range of tests was used, including sedimentation volume, viscosity, droplet size after dispersion in simulated gastric fluid, microscopic examination and content uniformity measurements to evaluate the properties of the anhydrous vehicle. The results showed that the vehicle exhibited consistent physical properties under varying conditions and maintained stability over time. This can be attributed to the unique blend of excipients in its formulation, which not only maintain its viscosity but also confer thixotropic behavior. The unique combination of viscous, thixotropic and self-emulsifying properties allows for rapid redispersibility, sedimentation stability, accurate dosing, potential drug solubility, dispersion and promotion of enhanced gastrointestinal distribution and absorption. Furthermore, the vehicle demonstrated long-term sedimentation stability and content uniformity for a list of 13 anhydrous suspensions. These results suggest that the anhydrous oral vehicle could serve as a versatile base for pediatric formulation, potentially filling an important gap in pediatric drug delivery. Future studies can further investigate its compatibility, stability and performance with other drugs and in different clinical scenarios.

A randomized, double-blind, controlled study evaluating the effects of two facial serums on skin aging.

BACKGROUND: Skin aging is a natural process that occurs because of oxidative stress. Facial skin aging is often concerning for individuals due to the exposure of the face. OBJECTIVES: To assess and compare the effects of two anti-aging facial serums on the following characteristics associated with facial skin aging: fine lines/wrinkles, age spots, firmness, elasticity, texture, radiance, tone, lifting, clarity, and complexion. METHODS: A 24-week, double-blind controlled study was conducted on 130 participants who were randomized into two groups: facial serum with Liposomal Blend and facial serum without Liposomal Blend. Clinical evaluations (Visual Analog Scale) and instrumental evaluations (Cutometer, SIAscope, and Clarity Pro image analysis) were performed at weeks 0 (baseline), 2, 4, 8, 12, and 24 to assess for changes in skin aging characteristics. RESULTS: A total of 123 participants completed the study; participants that used the facial serum with Liposomal Blend had significantly greater improvements in skin aging characteristics compared to those that used the facial serum without Liposomal Blend. This study shows that Liposomal Blend is a vehicle with the ability to enhance the anti-aging properties of the ingredients within the facial serum by facilitating its delivery into the underlying layers of the skin. Higher concentration of ingredients at the site of action could potentially lead to greater damage repair and improvements in signs of facial skin aging. CONCLUSION: By using Liposomal Blend, practitioners and pharmacists could potentially improve the delivery of the ingredients within their formulations into the skin, which may lead to increased treatment efficacy.

Evaluation of an Anhydrous Permeation-Enhancing Vehicle for Percutaneous Absorption of Hormones.

The efficiency and safety of hormone delivery through the skin partly depend on the appropriate choice of vehicle and the type of formulation. The present study reports the skin cytotoxicity, irritancy, and safety of a newly developed anhydrous permeation-enhancing base (APEB) and the percutaneous absorption of progesterone, testosterone, estriol, and estradiol in APEB formulations. Using the human skin EpiDerm model, cell death was not observed after 4 h of exposure to APEB and was 48% after 24 h, indicating its mild to non-irritating property. APEB did not change the expression level of skin cell proliferation markers including PCNA, MCL-1, iNOS, and NFκB proteins, and apoptosis was minimal after 8-h exposure. The in vivo skin irritation and sensitization evaluation of APEB using a Human Repeat Insult Patch Test showed no adverse reaction of any kind during the course of the study. These results indicate the safety of APEB on skin tissues. The hormone percutaneous absorption was performed using human cadaver abdomen skin tissues and the Franz diffusion system, and hormone concentrations were determined by ELISA. Absorption was observed as early as 2 h of application and accumulated after 24 h to 2851 ± 66 ng/cm2, 2338 ± 594 ng/cm2, 55 ± 25 ng/cm2, and 341 ± 122 ng/cm2 for progesterone, testosterone, estriol, and estradiol, respectively. A steady flux rate of absorption of the hormones was observed within 24 h of application. These results suggest that APEB can be used as a vehicle to deliver these hormones through the skin and into the bloodstream for hormone replacement therapy.

The Potential Effects of a Compounded Methylcobalamin Nasal Spray on Short-term Memory Loss After Intracranial Hemorrhage: A Case Report.

Short-term memory loss is a common complication after intracranial hemorrhage or traumatic brain injury. FDA-approved cholinesterase inhibitors for memory symptoms of Alzheimer's disease have not been proven effective for improving memory impairment resulting from a hemorrhagic event. The purpose of this case study was to present the potential effectiveness of a compounded nasal spray containing methylcobalamin in improving short-term memory function in a patient post-intracranial hemorrhage. The patient started to administer the methylcobalamin nasal spray once daily after suffering from short-term memory loss for four years. His verbal memory, visual memory, and quality of life were assessed by the Hopkins Verbal Learning Test-Revised, Benton Visual Retention Test, and the 36-Item Short Form Survey, respectively, at baseline and 30 days after treatment. The delayed recall test was repeated after 60 days. After 30 days of treatment, the patient received improved scores in both verbal and visual memory tests, as well as improved self-reported quality of life. The patient became less dependent on phone reminders in daily life. The improvement in delayed recall remained significant after 60 days of treatment. This case report suggests a potentially safe and effective therapy for attenuating short-term memory impairment after intracranial hemorrhage.

Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials.

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 -0.66 [95% CI, -1.28 to -0.04]; I2 = 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.

Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design.

Trimix is a widely prescribed penile injection for patients with erectile dysfunction and is only available as a compounded medication. The instability of alprostadil, one of the major ingredients of Trimix, has been a limiting factor in its utilization. There are published stability data for Trimix formulations that have been used to establish a beyond-use-date. However, a robust bracketed study that is shown to be reproducible is highly desirable and meaningful. The purpose of this study was to test the reproducibility of a bracketed stability study when the preparations were made by two different entities to provide beyond-use date information of Trimix preparations that cover a wide range of strengths. A validated stability indicating method was used to compare the stability of a bracketed Trimix - alprostadil 5 µg/mL to 45 µg/mL, papaverine 15 mg/mL to 30 mg/mL, and phentolamine 0.4 mg/mL to 5 mg/mL, and a single-strength preparation containing alprostadil 30 µg/mL, papaverine 30 mg/mL, and phentolamine 2 mg/mL that were compounded and stored following the same methods and conditions, but at two different practice settings. Beyond-use dates of 60 days and 64 days at cold temperature were obtained for the two preparations from two different settings. The consistent results confirmed the reproducibility of the bracketing designs used to determine the beyond-use dates of Trimix. The clinical value of these results stems from the availability of accurate and widely applicable stability data that can be referenced to establish beyond use dates of a number of Trimix preparations with various strength combinations.

A topical naltrexone formulation for surgical wound healing: A case report.

BACKGROUND: In current guidelines, there is no specific therapeutic recommendation for promoting surgical wound healing. Proper postsurgical wound care regimen can speed up wound healing and prevent abnormal scarring. AIMS: The purpose of this case study was to evaluate the effectiveness of a compounded topical formulation containing naltrexone in managing surgical wound in a patient after Mohs micrographic surgery (MMS). PATIENTS/METHODS: A patient started to apply the topical naltrexone formulation two days after the MMS on his hand. Images of the wound and a Patient Scar Assessment Questionnaire (PSAQ) were used to evaluate the clinical outcomes. RESULTS: The wound completely healed, and the hand function was fully recovered following application of the formulation for 2 weeks. No abnormal scarring was formed, and the scar was only slightly noticeable after 2 months. CONCLUSION: This case study demonstrated the effectiveness of the topical naltrexone formulation in surgical wound management.

Evaluation of the Efficacy and Stability of Compounded Pentoxifylline-containing XemaTop for Psoriasis.

Psoriasis is an inflammation-mediated skin disorder for which an efficacious topical treatment is yet to be identified. A new compounded topical formulation containing 10% pentoxifylline in XemaTop base was recently developed for psoriasis. Prior to its use in humans, an in vitro evaluation was performed to determine its efficacy in attenuating molecular markers associated with psoriasis using a three-dimensional psoriasis tissue model. After 5 days of topical exposure to the formulation, the levels of inflammatory cytokines IL-1ß, IL-6, and GM-CSF decreased by 20%, 94%, and 96%, respectively. The production of pro-collagen type I and fibronectin essential for cellular proliferation was also significantly inhibited with a concomitant thinning of the epidermis. These results suggest that 10% pentoxifylline in XemaTop is efficacious in inhibiting the biomarkers associated with psoriasis. Pentoxifylline in XemaTop was stable within 91 days when stored under refrigerated or ambient conditions. These biochemical and stability studies suggest that 10% pentoxifylline in XemaTop may be evaluated now in psoriasis patients.

In vitro evaluation of Naltrexone HCl 1% Topical Cream in XemaTop™ for psoriasis.

Psoriasis is a multifactorial skin disease involving abnormal cell proliferation and inflammation; an efficacious topical treatment is yet to be identified. A formulation containing 1% Naltrexone HCl in XemaTop™ base was compounded, characterized and evaluated in vitro as a possible treatment for psoriasis. A three-dimensional psoriasis tissue model was exposed to the formulation for 2 or 5 days and analyzed for the level of markers of cellular proliferation, and inflammatory cytokine IL-6. Using immunohistochemical staining, the level of Ki67 protein significantly decreased in the drug-treated tissues. Western blot analysis showed 86% and 53% down-regulation of other proliferation markers PCNA and CYCLIN D1, respectively, after 5-day exposure. The pro-survival Wnt/ß-catenin pathway was compromised as indicated by 57% decrease in the level of ß-CATENIN and down-regulation of its down-stream targets including CYCLIN D1 (decreased by 53%), c-MYC (63%), c-JUN (92%) and MET (96%) proteins. Likewise, the PI3K/AKT/mTOR pathway was significantly inhibited by 1% Naltrexone HCl in XemaTop™, suggesting protein synthesis was affected. The production of IL-6 was inhibited by 70% in drug-treated tissues. These results suggest that the compounded drug is efficacious in down-regulating molecular markers associated with the pathogenesis of psoriasis. Low-dose Naltrexone in XemaTop™ was stable within 180 days when stored under refrigerated or ambient conditions. These results provide a basis for a clinical evaluation of 1% Naltrexone HCl in XemaTop™ in psoriasis patients.

Physicochemical Stability of Extemporaneously Prepared Methylcobalamin Injections in the Presence and Absence of Preservative and the Impact of Light Exposure.

Methylcobalamin, one of the two active forms of vitamin B12, is the most effective analog in permeation and in transportation of neurons in subcellular organelles. Formulations of methylcobalamin are only commercially available in a few countries, which make them inaccessible for most patients. Extemporaneously prepared injections become the only option for those patients. The objective of this work is to study the physical and chemical (ultrahigh- performance liquid chromatography stability-indicating method) stabilities of methylcobalamin injections in the presence and absence of preservative during 181 days (considering the stability limit as 90% of initial concentration of methylcobalamin). The light exposure stability of injections in amber serum vials or clear syringes, solution in amber or clear glassware under typical pharmacy, clinical, and laboratory settings are also presented. Methylcobalamin injections, regardless of the concentrations and inactive ingredients, remained stable for at least 181 days at room temperature when stored in amber serum vials and protected from light. These experimental data suggested that the methylcobalamin injection solutions should be protected from light completely and light exposure in pharmacy, clinical, and laboratory setting should be minimized.

Physical and Chemical Stability of Estriol 0.025% to 1% Vaginal Creams (VersaBase).

Estrogen replacement therapy is often recommended when female patients present with lower than normal physiologic levels, such as patients going through menopause. The physical and chemical stability of estriol 0.25 mg/g and 10 mg/g vaginal creams (VersaBase) was tested over a period of 182 days, at room temperature and refrigerated conditions, in order to determine the corresponding beyond-use date. The physical characterization consisted in observing all samples for color/appearance and odor, and testing for pH, whereas the chemical characterization consisted in ultra-performance liquid chromatography assay testing. Both vaginal creams were proven physically and chemically stable, and the ultra-performance liquid chromatography method was proven stability indicating. As a result, the beyond-use date of the estriol 0.025% to 1% vaginal creams (VersaBase), in electronic mortar and pestle plastic jars, is six months at both room temperature and refrigerated conditions.

Effects of Compounded Stanford Modified Oral Rinse (MucoLox) on the Survival and Migration of Oral Keratinocytes and Fibroblasts: Implications for Wound Healing.

Several oral rinses are commercially available to alleviate the symptoms of oral mucositis. Prolonged retention of active pharmaceutical ingredients in the oral cavity is a major problem. In this study, we modified the Stanford oral rinse by including a proprietary mucoadhesive polymer called MucoLox, which we hypothesized would improve active pharmaceutical ingredient mucoadhesion. Characterization of this newly compounded oral rinse showed absence of cytotoxicity in human oral keratinocyte and fibroblast cell lines. The compounded formulation significantly stimulated the migration of these two cell lines in Oris Cell Migration Assay plates, better than the reference commercial product Magic mouthwash. Based on this in vitro study, the new Stanford modified oral rinse with MucoLox is safe and may promote healing of oral mucositis.

Physical and Chemical Stability of Budesonide Mucoadhesive Oral Suspensions (MucoLox).

Budesonide is a corticosteroid that has been shown effective in the treatment of eosinophilic esophagitis, but there are currently no commercial medicines to treat this chronic allergic/immune condition, despite its prevalence in the U.S. Therefore, pharmaceutical compounding is the alternative choice to meet the therapeutic need of eosinophilic esophagitis patients. Two budesonide mucoadhesive oral suspensions (1 mg/10 mL and 2 mg/10 mL) were developed using the compounding vehicle MucoLox, a proprietary mucoadhesive polymer blend that promotes mucosal adhesion. The physical and chemical stability of the oral suspensions was tested over a period of 182 days, at room temperature and refrigerated conditions, in order to determine the corresponding beyond-use date. The physical characterization consisted in observing all samples for color/appearance and odor, and testing for pH and density, whereas the chemical characterization consisted in ultra-performance liquid chromatography assay testing. Both oral suspensions were proven physically and chemically stable, and the ultra-performance liquid chromatography method was proven stability indicating. As a result, the beyond-use date of the budesonide 1-mg/10-mL and 2-mg/10-mL mucoadhesive oral suspensions (MucoLox), in amber plastic bottles, is six months at both room temperature and refrigerated conditions.