In Vitro Lipolysis Model to Predict Food Effect of Poorly Water-Soluble Drugs Itraconazole, Rivaroxaban, and Ritonavir.

It is desirable to predict positive food effect of oral formulations due to food mediated dissolution enhancement of lipophilic drugs. The objective was to assess the ability of in vitro lipolysis to anticipate a positive food effect. Tested formulations included rivaroxaban and itraconazole, where some formulations, but not all, exhibit a positive food effect in vivo in humans. Amorphous solid dispersion formulations of ritonavir, which exhibit a negative food effect in vivo in humans, were also studied. Fe-lipolysis and Fa-lipolysis media representing fed and fasted intestinal conditions were used. Results show frequent agreement between in vitro lipolysis predictions and in vivo human outcomes. For rivaroxaban, food effect of unformulated active pharmaceutical ingredient (API) and products were correctly predicted where 2.5 mg and 10 mg strengths did not show any food effect; however, 20 mg did show a positive food effect. For itraconazole, all four products were correctly predicted, with Sporanox, Sempera, and generic capsules having a food effect, but Tolsura not having a positive food effect. For ritonavir, lipolysis predicted a positive food effect for API and Norvir tablet and powder, but Norvir products have negative food effect in vivo in humans. Overall, the lipolysis model showed favorable predictability and merits additional evaluation.

Tobacco and Marijuana Initiation Among African American and White Young Adults.

INTRODUCTION: African American youth use marijuana at similar rates and tobacco at lower rates compared with white youth; however, in adulthood, tobacco use is similar. Tobacco and marijuana use are closely associated; differing initiation patterns may contribute to observed racial differences in tobacco prevalence by age. Therefore, it is important to assess tobacco and marijuana initiation patterns by race. METHODS: Data were obtained from 56,555 adults aged 18-25 who completed the 2005-2012 National Survey on Drug Use and Health. The analysis was restricted to those who reported ever use of marijuana and combustible tobacco (cigarettes and/or cigars). Three mutually exclusive categories of initiation patterns were evaluated: use of marijuana before tobacco; marijuana and tobacco at the same age; and tobacco before marijuana. Multivariable regression models were used to assess changes over time and compare these outcomes by race while controlling for sociodemographics, risk perceptions, and current substance use. RESULTS: In 2005, 26.6% of African American and 14.3% of white young adults used marijuana before tobacco, compared with 41.5% of African American and 24.0% of white young adults in 2012 (P < .001). Overall, African American young adults had greater odds of using marijuana before tobacco (AOR = 1.79; 95% CI: 1.67, 1.91) compared with whites. CONCLUSION: African American young adults were more likely than whites to use marijuana before tobacco and both groups were increasingly likely to use marijuana before tobacco over time. A greater understanding of how marijuana initiation interacts with tobacco initiation could inform more effective tobacco and marijuana use prevention efforts. IMPLICATIONS: Among ever users of combustible tobacco and marijuana, greater proportions of African American young adults used marijuana before tobacco or at the same age than their white counterparts. Moreover, both African Americans and whites were more likely to use marijuana before tobacco in 2012 compared with 2005. Tobacco control policy may benefit from a broader understanding of the patterns of initiation to tobacco and marijuana use. Some public health interventions aimed at preventing and reducing combustible tobacco use among African American young adults may be strengthened by considering marijuana use.

Parent perceptions important for HPV vaccine initiation among low income adolescent girls.

OBJECTIVE: The study aims were to assess the influence of provider recommendations on parental vaccine perceptions and identify the most potent parent vaccine perceptions for HPV vaccine series initiation considering provider recommendation strength. METHODS: We administered a questionnaire and assessed HPV vaccine claims among a stratified-random sample of parents of 9-17 year old girls enrolled in Florida's Medicaid and the Children's Health Insurance Program. Using multivariate analyses, we evaluated the associations between: (1) parent vaccine perceptions and provider recommendation strength, and (2) parent vaccine perceptions and HPV vaccine series initiation (≥1 vaccine claim or positive parental report) controlling for provider recommendation strength. RESULTS: The majority of the 2422 participating parents agreed that the HPV vaccine was safe (61%), would not make girls more likely to have sex (69%), and prevented cervical cancer (71%). About half (44%) reported receiving a strong provider recommendation. Compared to parents without recommendations, parents with strong recommendations had 2 to 7 times higher odds of agreeing that: vaccines are safe, the HPV vaccine is safe, not concerned about side effects, and the vaccine prevents cervical cancer. Even when considering provider recommendation strength, HPV vaccine series initiation was more likely among girls of parents who agreed rather than disagreed that the HPV vaccine was safe [odds ratio (OR)=5.8, 95% confidence interval (CI)=3.1, 11.1], does not cause sex (OR=2.0, 95% CI=1.2, 3.4), prevents cervical cancer (OR=2.0, 95% CI=1.0, 3.4), and prevents HPV infections (OR=1.8, 95% CI=1.0, 3.0). CONCLUSIONS: Parent concerns about HPV vaccine are similar to their concerns about other vaccines. Providers should focus HPV vaccine discussions with parents on vaccine safety and illness prevention.