D-optimal mixture design: Formulation development, mechanical characterization, and optimization of curcumin chewing gums using oppanol® B 12 elastomer as a gum-base.

Curcumin (CUR) chewing gums have potential therapeutic benefits to head and neck cancer patients. The objective of this work was to develop medicated chewing gums (MCGs) with high CUR loading and desirable mastication properties. This was accomplished by evaluating the effect of five gum ingredients: (X1) polyisobutene, (X2) polyvinyl acetate, (X3) wood rosin, (X4) wax, and (X5) CUR on the mechanical properties of the MCGs using a 25-run, five-factor, two-level D-Optimal mixture design. CUR MCGs were prepared by the conventional fusion method for making chewing gums. They were characterized by a two-bites texture and uniaxial tension tests to generate force-displacement curves from which the cohesiveness (Y1), springiness (Y2), chewiness (Y3), compressibility (Y4), resistance to extension (Y5), and extensibility (Y6) were measured. Observed responses were used to generate polynomial models correlating the independent with the dependent variables. Elasticity and stiffness of the gums were found to be readily impacted by PIB and CUR levels. Fitted models were then used to predict a gum composition that has comparable mechanical properties to commercially procured chewing gums. The optimized MCG was loaded with 50% of either CUR or CUR/SBE-ß-CD inclusion complex and tested in vitro for drug release. Although no differences in mechanical properties were observed, substituting CUR with the inclusion complex was found to significantly enhance drug release. This study highlighted the impact of each gum ingredient on the quality of the MCGs and demonstrated the feasibility of preparing chewing gums with up to 50% drug loading.

Mechanical Characterization and Dissolution of Chewing Gum Tablets (CGTs) Containing Co-compressed Health in Gum® and Curcumin/Cyclodextrin Inclusion Complex.

Curcumin chewing gums could be therapeutically beneficial if used by the head and neck cancer patients. High curcumin loading in chewing gums however is needed to achieve desired therapeutic effect. Preparing gums with high drug load is nonetheless challenging because of the negative impact of solids on their masticatory properties. The use of liquid flavors was found to partially solve this problem. The objectives of this study were to (1) determine the maximum amount of curcumin that can be loaded into co-compressed chewing gums made from Health in Gum® as the base and flavored with 1.5% peppermint oil, (2) determine if addition of sweeteners can improve the yield strength and compressibility of the gums when examined by a texture analyzer, (3) examine the effect of temperature over a storage period of one month on the physical stability of the chewing gums, and (4) study the impact of substituting curcumin with its inclusion complex with SBE-ß-CD on drug release. It was found that when flavored, Health in Gum® could load up to 25% curcumin by weight without compromising its masticatory properties. When tested for drug release, SBE-ß-CD was found to significantly increase the amount of curcumin dissolved within 30 min. Despite poor drug release from gums loaded with insoluble curcumin, the fragmentation of the gums during mastication by the Erweka tester is nonetheless expected to produce a suspension for absorption in the lower GIT. This study demonstrated how modulating gum composition and storage conditions can impact the mechanical properties of chewing gums with high solids content.

Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

The ObGyn clerkship: are students denied the opportunity to provide patient care and what is the role of gender?

OBJECTIVE: We sought to study the frequency, and reasons that third-year medical students on an ObGyn clerkship are denied the opportunity to be involved in patient care. METHODS: Students from four hospitals affiliated with the University of Connecticut Medical School completed an anonymous postclerkship survey. RESULTS: Among the 157 students studied (66 males and 91 females), 51% (n = 80) were denied the opportunity to participate in a gynecologic examination and 47% (n = 73) were denied the opportunity for routine ObGyn care by patients. Among these students, 55% (n = 44) and 38% (n = 28) stated that being male was the reason they were excluded from gynecologic and routine care, respectively. Of the 80 students who were denied involvement in a gynecologic examination, 81% (n = 65) were denied involvement by clinic patients. Of the 44 males who stated they were denied the opportunity to be involved in a gynecologic examination due to their gender, 89% (n = 39) were refused by clinic patients. Compared with female students, male students are statistically more likely to be denied the opportunity to be involved in gynecologic examinations (RR = 1.69 [1.24-2.29]), especially by clinic patients (RR = 2.07 [1.41-3.03]). CONCLUSION: A significant number of students were denied the opportunity to be involved in ObGyn care experiences. More frequently male students were denied involvement in care, with a higher incidence among clinic patients. We hypothesize that being denied involvement provides a negative perception of the ObGyn specialty, especially to male students, possibly affecting their decision to choose ObGyn training. PRECIS: A significant number of medical students, particularly males, were denied involvement in patient care, primarily by clinic patients, during the ObGyn clerkships.