A Qualitative Study of Underrepresented Minority (URM) Student Pharmacists' Intersectionality and Professional Identity Formation.

OBJECTIVE: To determine how underrepresented minority (URM) student pharmacists' intersectionality affects professional identity formation early in their academic career. METHODS: A qualitative study was undertaken. All students from Classes 2022 through 2025 at Texas A&M University School of Pharmacy were required to engage in reflection on a personal statement of philosophy of practice early in their first year of pharmacy as part of the structured longitudinal co-curricular course requirement. Statements of the URM students who referenced their intersecting identities were selected for deductive analysis per Bingham and Witkowsky and inductive analysis using Lincoln and Guba's approach to content analysis. RESULTS: Of the 221 URM student pharmacists within the 4 cohorts who submitted a statement, 38 statements (92% Hispanic students) met the inclusion criteria. Student hometowns and the identity domains of the individual, relational, and collective were selected a priori for the deductive analysis. Students most often referenced individual identity characteristics that fit under the Principles I, IV, V, and VII of the Code of Ethics for Pharmacists. Three themes emerged from the inductive analysis: (1) defining experiences and resulting realizations, (2) motivating forces, and (3) aspirations as a pharmacist. A working hypothesis was developed. CONCLUSION: The URM students' intersecting identities (race, ethnicity, socioeconomic class, and belonging to an underserved community) influenced their early professional identity formation. The desire to bring about racial uplift was observed among the Hispanic students as early in their P1 year through the School's required co-curricular reflection. Such reflective practice serves as an effective vehicle for the students to recognize their intersecting identities that impact their professional identity.

In-use stability assessment of FDA approved metformin immediate release and extended release products for N-Nitrosodimethylamine and dissolution quality attributes.

Metformin is a widely used first-line oral antidiabetic agent. TheFood and Drug Administration (FDA) confirmed the presence of the ofN-nitrosodimethylamine (NDMA) impurity, a carcinogenic, above the acceptable daily intake (ADI, 96 ng/day) in certain metformin products. The objective of the present study was to assess in-use stability of commercial metformin products for NDMA and dissolution quality attributes. Four immediate-release (M1-M4) and six extended-rerelease (M5-M10) metformin products were evaluated in the stability testing. All products were repacked in pharmacy vials and stored at 30 °C/75% RH for 12 weeks. Five products (M2, M3, M5, M7 and M10) had NDMA level above ADI limit (96 ng/day) before in-use stability exposure. NDMA in M2 (1164 ± 52.9 ng/tablet) and M3 (3776 ± 351.9 ng/tablet) products were 12 and 39 folds of ADI, respectively. Similarly, ER products, M5 (191 ± 94.1 ng/tablet), M7 (1473 ± 47.3 ng/tablet) and M10 (423 ± 55.8 ng/tablet) exhibited NDMA of 1.9, 15.3 and 4.4 folds of ADI, respectively. The impurity level significantly (p < 0.05) increased after 12-week stability exposure to 2.72, 2.47, 2.23 and 2.78 folds of initial values in M2, M3, M7 and M10. In summary, these findings suggested that carcinogenic impurity generation was affected by in-use stability condition exposure and it is expected that several more products currently in the market may also be recalled soon.

Preparation and characterization of dicarboxylic acids salt of aripiprazole with enhanced physicochemical properties.

The focus of present work was to prepare salt of aripiprazole (APZ) with dicarboxylic acids to improve physicochemical properties the drug. Dicarboxylic acids used in the study were malonic acid, maleic acid and succinic acid. The salts were prepared with solubilization-crystallization method. The salts were characterized for pH-solubility, dissolution, and stabilities. The Fourier infrared spectroscopy, X-ray powder diffraction, differential scanning calorimetry and near infrared chemical imaging indicated formation of new solid phase. pH-solubility profiles of the salts were similar to the drug except higher solubility were observed in the salts at all tested pH. The highest solubility was observed for APZ-Malonate salt among all the prepared salts. The solubility curve was inverted 'V' shape for APZ-maleate and APZ-succinate while it was inverted 'U' shape for APZ-malonate. The water solubility of APZ, APZ-malonate, APZ-maleate and APZ-succinate were 0.07 ± 0.02, 3503.9 ± 37.4, 269.3 ± 6.9 and 729.4 ± 9.4 µg/mL, respectively. The dissolution was 2.9 ± 0.4, 18.4 ± 3.9, 19.5 ± 1.4 and 36.6 ± 4.0% in 45 min for APZ, APZ-maleate, APZ-malonate, and APZ-succinate. The stabilities of the salts were similar to the drug. Thus, salts improved the physicochemical properties of the drug, and have similar stability profiles as that of APZ.

Additive Manufacturing with 3D Printing: Progress from Bench to Bedside.

Three-dimensional (3D) printing was discovered in the 1980s, and many industries have embraced it, but the pharmaceutical industry is slow or reluctant to adopt it. Spiritam® is the first and only 3D-printed drug product approved by FDA in 2015. Since then, the FDA has not approved any 3D-printed drug product due to technical and regulatory issues. The 3D printing process cannot compete with well-established and understood conventional processes for making solid dosage forms. However, pharmaceutical companies can utilize it where mass production is not required; rather, consistency, precision, and accuracy in quality are paramount. There are many 3D printing technologies available, and not all of them are amenable to pharmaceutical manufacturing. Each 3D technology has certain prerequisites in terms of material that it can handle. Some of the pertinent technical and regulatory issues are as follows: Current Good Manufacturing Practice, in-process tests and process control, and cleaning validation. Other promising area of 3D printing use is printing medications for patients with special needs in a hospital and/or pharmacy setting with minimum regulatory oversight. This technology provides a novel opportunity for in-hospital compounding of necessary medicines to support patient-specific medications. However, aspects of the manufacturing challenges and quality control considerations associated with the varying formulation and processing methods need to be fully understood before 3D printing can emerge as a therapeutic tool. With these points in mind, this review paper focuses on 3D technologies amenable for pharmaceutical manufacturing, excipient requirement, process understanding, and technical and regulatory challenges.

Effect of processing parameters and controlled environment storage on the disproportionation and dissolution of extended-release capsule of phenytoin sodium.

Phenytoin sodium (PS) is a narrow therapeutic index drug that dictates maintenance of narrow plasma concentration of the drug. This requires a good quality product that meets regulatory specifications throughout shelf-life as well as during the usage period. Quality of the drug product may change if not develop in a scientific fashion which may have ramifications on clinical outcome. The focus of the study was to understand the effect of process variables and storage conditions on the disproportionation and phase transformation of the drug, and dissolution of extended-release capsules of PS. Four formulations were prepared to contain either powder blend or granules of PS with commonly used excipients. The granules were prepared in a high shear mixture by granulating with water, ethanol or mixture thereof. The capsules were stored in pharmacy vials for 4-weeks at 40 °C/75% RH and 30 °C/65% RH. Formulations were characterized by spectroscopies (FTIR, NIR, and chemical imaging), X-ray powder diffraction (XRPD), dissolution and assay. Granules filled capsule did not meet USP dissolution specifications and there was a significant decrease in dissolution on exposure to stability conditions. Dissolution decreased from 77.56 ±â€¯3.83% to 42.34 ±â€¯4.31%, and 63.96 ±â€¯6.12 to 46.53 ±â€¯2.91 in physical mixture and water granulated formulations, respectively, after four weeks exposure at 40 °C/75% RH. Spectroscopic (NIR, FTIR, and chemical imaging) data indicated disproportionation of the drug during the storage period. Moreover, XRPD data explained a decrease in dissolution in the initial granules filled capsules as well as temperature and humidity exposed samples. It indicated the phase transformation of the drug and/or excipients, disproportionation and/or interactions. These changes further accelerated on exposure to stability conditions. In conclusion, our studies indicated the significant effect of process variables and stability conditions on the critical quality attributes of PS extended-release capsule that has the potential impact on the clinical performance of the product.

Cholorpheniramine tannate complexes: physicochemical, chemometric, and taste masking evaluation.

The focus of present investigation was to evaluate the tannic acid (TA) complexes of cholorpheniramine maleate (CPM) and characterize it by a variety of physicochemical, dissolution, and electronic tongue methods. The complexes were prepared in various molar ratios by solvent evaporation method. They were characterized by spectroscopic, thermal, powder X-ray, electronic tongue, solubility and dissolution methods. FTIR (infrared red) spectra showed complex formation between the TA and CPM. Complex formation has significantly lowered the drug solubility and sustained its release for more than 24 h in phosphate buffer pH 6.8. On the contrary, the release was much faster in the presence of Avicel PH 113 in the same molar ratio complex. The complex formulation has suppressed the bitter taste of CPM as indicated by Euclidean distance in electronic tongue evaluation. NIR-CI (near infrared chemical imaging) showed lower skew value that indicated the homogenous distribution of formulation components. The chemometric models were also developed using the NIR data. The model based on second derivative data was better in predicting the TA and CPM loading as indicated by higher values of R, R(2) and lower values of root mean square error and standard errors. Furthermore, it has a better accuracy and less biased in comparison to other models. In conclusion, the CPM tannate has a sustained release behavior and excipients play a major role in modifying its release. Additionally, the complexes with varying molar ratio of tannate to CPM have differential taste masking abilities than that of the pure drug.

Preparation and characterization of demeclocycline liposomal formulations and assessment of their intraocular pressure-lowering effects.

UNLABELLED: The objective of the present study is to enhance the ocular permeability and to study the ocular disposition of demeclocycline (DEM), liposomal topical formulation for treatment of elevated intraocular pressure using Male New Zealand albino rabbits as an animal model. METHODS: Different liposomal formulations of the DEM were prepared and characterized for their drug entrapment, drug-liposome affinity and the in vivo distribution of DEM in various ocular tissues. Liposomal formulations of promising drug distribution within the various ocular tissues have been scaled up for the in vivo intraocular pressure (IOP) measurements by Pneuma-tonometer using different dosing regimens. RESULTS: The amounts of drug entrapped in the charged liposomal formulations were comparable and lower than that entrapped with neutral ones. DEM was found to be more concentrated (69-95%) in the lipid phase of the liposome. The concentrations of DEM in the cornea, aqueous humor, and conjunctiva were 4.76, 2.18, and 23.32 microg/g of tissue, respectively. Test formulations have shown significant reductions in the IOP on using different treatment protocols. CONCLUSION: Preparation of liposomal formulations of DEM has substantially enhanced its transcorneal transport. Furthermore, the test formulations have shown promising and long-lasting intraocular pressure-lowering effect comparable with that of pilocarpine formulation as a control.

Percutaneous permeation of enantiomers and racemates of chiral drugs and prediction of their flux ratios using thermal data: a pharmaceutical perspective.

Albeit pharmacological, pharmacokinetic, and toxicological differences between enantiomeric pairs or between the pure enantiomers and racemate of chiral drugs are known to exist for decades, we are just beginning to realize that there are apparent differences between these species with respect to their percutaneous permeation as well. Such differences in permeation are likely to be enhanced when chiral drugs are formulated with chiral excipients, necessitating a careful assessment of the effect of formulation excipients on the permeation as well as the overall therapeutic outcomes. The in vitro transport data from the preclinical investigations, using laboratory animal models and/or in vitro cell culture systems, must be carefully validated in vivo as there are differences between these models and the human skin. Mathematical models such as MTMT that utilize the interdependence of certain physicochemical characteristics and percutaneous permeability have a predictive value in assessing the flux behavior of enantiomers and racemates.

Effect of Azone upon the in vivo antiviral efficacy of cidofovir or acyclovir topical formulations in treatment/prevention of cutaneous HSV-1 infections and its correlation with skin target site free drug concentration in hairless mice.

The purpose of this study is to examine the influence of Azone upon the skin target site free drug concentration (C(*)) and its correlation with the in vivo antiviral efficacies of cidofovir (HPMPC) and acyclovir (ACV) against HSV-1 infections. Formulations of HPMPC and ACV with or without Azone were used. The in vitro skin flux experiments were performed and the C(*) values were calculated. For the in vivo efficacy studies, hairless mice cutaneously infected with HSV-1 were used and three different treatment protocols were carried out. The protocols were chosen based upon when therapy is initiated and terminated in such a way to assess the efficacy of the test drug to cure and/or prevent HSV-1 infections. A finite dose of the formulation was topically applied twice a day for the predetermined time course for each protocol and the lesions were scored on the fifth day. For ACV formulation with Azone, the C(*) values and hence the in vivo efficacy were much higher than those for that without Azone. In protocol #1, however, early treatment did not increase the in vivo efficacy of ACV when compared with the standard treatment protocol #3. In protocol #2 where the treatment was terminated on the day of virus inoculation, the efficacies for both ACV formulations were completely absent. Although the estimated C(*) values for HPMPC formulations with and without Azone were comparable, formulation with Azone was much more effective than that without Azone in all treatment protocols. HPMPC formulations with Azone at similar flux values were much more effective in "treating and preventing" HSV-1 infections than those without Azone. For ACV formulations, in contrast, addition of Azone has failed to show any effect on the preventive in vivo antiviral efficacy and the enhancement of ACV in vivo antiviral efficacy was merely the skin permeation enhancement effect of Azone.

Preparation and characterization of coenzyme Q10-Eudragit solid dispersion.

A solid dispersion of Coenzyme Q10 and Eudragit L 100-55 was prepared using solvent evaporation method. Solid dispersion, physical mixture, and pure compound were then characterized using differential scanning calorimetry and powder x-ray diffraction. Solubility of CoQ10 in different surfactant media was measured, and a suitable dissolution medium was developed to compare the dissolution patterns of the solid dispersion, physical mixture, and the pure compound. Combining labrasol with different surfactants in dissolution media demonstrated an additive effect on CoQ10 solubility. The solubility of CoQ10 in a 4% Labrasol/2% Cremophor EL solution was 562 microg/ml, which was five times higher than the combined solubility in 5% Labrasol (91 microg/ml) and 5% Cremophor EL (7.8 microg/ml). Moderate change in the crystalline pattern of CoQ10 was observed, which was attributed to solvent displacement rather than the degree of crystallinity change. The dissolution test indicated that the in-vitro release of Coenzyme Q10 from its solid dispersion was much faster than its physical mixture, which in turn was faster than the pure drug. The amount of drug released in 12 hours from solid dispersion, physical mixture, and the pure drug was 100, 26.5 and 12.5% respectively. CoQ10 was photostable throughout the dissolution experiments.

Comparative development of SIRC rabbit corneal cells grown on polycarbonate- and polyester-based filters.

Statens Seruminstitut Rabbit Cornea (SIRC) cells were grown on sterile polycarbonate- and polyester-based filter inserts to evaluate the feasibility of substituting the polyester-based filter inserts for use in a previously developed permeability model. The two filter types were compared for differences in cellular growth rate and morphological changes following days 3, 7 and 10 in culture. There were no significant differences in the number of cell layers formed on any day examined. The numbers of cell layers formed with the polycarbonate-based filter inserts were 1.75 +/- 0.09, 2.53 +/- 0.14 and 2.93 +/- 0.16, for days 3, 7 and 10, respectively. The numbers of cell layers formed with the polyester-based filter inserts were 1.79 +/- 0.07, 2.23 +/- 0.11 and 2.90 +/- 0.13, for days 3, 7 and 10, respectively. The SIRC cells had a similar comparative morphology on each of the above days. Active cell growth was seen on each day with signs of maturation evident by day 7 in culture. The polyester-based filter inserts can be substituted in the previously established permeability assay without alteration of morphology or rate of growth, thus allowing confirmation of cell confluency prior to use in the permeability assay. It will also allow for photographic documentation of cell injury prior to recovery studies, without necessitating the preparation of extra samples for fixation at the time of initial injury. Future studies will be required to determine if there will be any alteration in the rate of permeability with a previously tested standard, before adoption of the new filter.