Evaluating the Bioavailability of Carbamazepine Using a Novel SNEDDS Formulation

Carbamazepine (CBZ) is an anticonvulsant drug primarily used to treat epilepsy, bipolar disorder, trigeminal and glossopharyngeal neuralgia. CBZ is a lipophilic, poorly soluble drug that belongs to the class-2 category according to the Biopharmaceutics Classification System. As a class-2 drug, the plasma concentration of CBZ is limited by its ability to diffuse across biological membranes. To increase its bioavailability, different methods such as crystal modifications, particle size reduction, amorphization, cyclodextrin complexation, pH modification, and self-emulsification were explored. Of these methods, Self Nano Emulsifying Drug Delivery Systems (SNEDDS) have shown to reduce particle size of CBZ molecules and improve its solubility. However, the bioavailability of CBZ administered as SNEDDS are not yet investigated. Given this background, the current study proposes to evaluate the bioavailability of these novel drug delivery systems using a rat model. The study is designed as a randomized controlled crossover experiment using 10-12 Sprague-Dawley rats divided equally into two groups. For this study, blood samples will be collected at 5, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after administering two different formulations of CBZ nanoemulsions and stored at -20°C until ready for analysis. Plasma concentrations of CBZ will be determined by HPLC method. An unpaired t-test will be used to compare the significance between the two sets of data

Evaluating the Bioavailability of Carbamazepine Using a Novel SNEDDS Formulation

Central to the mechanism of how drugs work are the concepts of solubility and bioavailability. Drugs enter the body via absorption into the bloodstream, arrive at the target location, and bind to receptors to cause an effect. Drugs need to be soluble enough to pass through the cell membrane to enter and exit the bloodstream. Higher solubility generally correlates to higher bioavailability. Additionally, the smaller the particle size, the easier the drug will pass through the membrane into the blood plasma. Researchers have designed a system to categorize solubility class: Class I being high permeability and high solubility, Class II high permeability and low solubility, Class III low permeability and high solubility, and Class IV low permeability and low solubility. The study will use a Class II anticonvulsant, carbamazepine (CBZ). CBZ is a suitable candidate for this study because it requires a higher bioavailability due to its need to cross the blood brain barrier and act on the trigeminal nucleus. To increase bioavailability researchers have tried crystal modifications, particle size reduction, amorphization, cyclodextrin complexation, pH modification, and self-emulsification. These methods have been successful at increasing bioavailability, but this experiment will focus on reducing particle size into a new self-emulsifying formulation. In particular, the formulation of CBZ in this study is a self nano-emulsifying drug delivery system (SNEDDS), which shows more promise than previous methods to increase bioavailability. This study will create a SNEDDS formulation as a nasal nebulizer mist delivery and compare it to a FDA approved oral suspension using a crossover rat model design. Sixteen Sprague-Dawley rats will be ordered through Central State University and normalized to the study environment for a minimum of one week. Pending IACUC approval from Central State University, the tail vein method will be used to collect blood samples. The samples will be stored until needed for analysis using ELISA, enzyme-linked immunosorbent assay, which will be used to determine the concentration of CBZ in blood plasma

International Multi-Site Gap Analysis Study to Identify Areas of Health Service Needs in Short-Term Medical Missions

Purpose: To identify and assess the needs of health care services in global medical missions. Methods: Every year, many health care professionals and their students travel abroad to developing countries to provide health care services to the under-served, indigent, and under-insured populations through medical missions. The large number and wide scope of these medical mission trips begs the question as to how effective these services are meeting the health care needs of these populations. A literature search in Pubmed, IPA, CINAHL and Cochrane indicated that there is a large gap in the literature evaluating the suitability of mission services in developing countries. A prospective cross-sectional observational multi-site study was then conducted. The sites included India, Honduras, Jamaica, Swaziland, Togo, Malawi, Cambodia, and the Dominican Republic. The study began in January 2014 and continued through April 2014. Cedarville University faculty from Pharmacy (7), Nursing (4), and Missions Involvement Services (MIS-1) were selected and interviewed based on medical missions’ involvement. The primary and secondary endpoints were to identify services needed by the patients, then for the sites and the teams accordingly. A questionnaire consisting of five items was created for this assessment: Missions location, services for patients, resources for patient/caregivers, sites, and teams were evaluated. Interviews were set up and completed according to the study time line. Results: Patient education (81.8%) was identified as the most important health care need followed by transportation (36.4%). Pharmacist Intervention and reference materials were identified as the key needs for the sites (72.7%) followed by education for health care workers (54.5%). Education and preparation were the most important needs for the teams. Many of these needs overlapped between locations. Conclusion: Evidently patient education is a paramount need for the sites assessed. Additionally, funding to support these missions is integral for patient care. The results of this need assessment study will be used to fill the literature gap in this area and seek funding opportunities for the services

Multi-State Gap-Analysis Research to Identify Resources of Need for Free Clinics that Service Indigent, Underinsured, and Underserved Populations

Purpose: To identify specific services and resources to best meet the needs of patients and providers of free medical and pharmacy clinics for underserved, underinsured and indigent patients. Methods: Access to affordable medical care for the underserved, underinsured, and indigent populations has been a primary focus of controversy among medical professionals for years. Despite teams of healthcare professionals, organizations, and health departments implemented models to care for these populations, there are still limited resources available. A literature search in Pubmed, IPA, CINAHL and Cochrane identified a large gap evaluating a need assessment of free medical clinics. A prospective cross-sectional multi-state three-arm pilot study was conducted from October 2013 to August 2014. Nine clinics in the states of Ohio, Kentucky, and Indiana were selected based on interdisciplinary practice foci. Clinics were interviewed telephonically to establish interest in participation. The study had primary, secondary, and tertiary endpoints orderly. These endpoints evaluated the most desired services for each clinic, site perceptions, willingness to collaborate, and timeline for service implementation to enhance patient care. Visits were made to the clinics between April and May 2014. A questionnaire consisting of 12 items was created to assess the following areas: patient population, services for patients, patients and providers perspectives on needs, most needed resources, site willingness for collaboration and desired timeline for service implementation. Interviews were conducted according to the study timeline. Results: IT personnel (55.6%) was identified as the most common need among the clinics followed by grant assistance (44.4%) as well as administrative personnel (44.4%). Forty four (44.4%) needed assistance with Grant writing and resources. Eight of the nine sites were willing to collaborate, and all sites desired implementation as soon as possible. Many of these needs overlapped between sites. Conclusion: Evidently IT personnel was a paramount need. There was a strong desire to collaborate, and an urgent desired timeline implementation. Funding to support these efforts is integral for patient care. The results of this need assessment study will be used to fill the literature gap in this area and seek funding opportunities for the services