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Improved Formulations for Approved First and Second line anti-Tuberculosis (TB) Drugs


Background There is an urgent need to develop alternative formulations of approved first and second line anti-TB drugs for pediatric use and also to simplify administration. There are few child-friendly formulations of pediatric first and second-line anti-TB medications available to practitioners in the US and globally. It is standard practice to cut or crush un-scored adult tablets and administer them to children in juice or other palatable substances. This has significant potential to deliver incorrect and highly variable doses to children, contributing to ineffective treatment. While consideration of pediatric applications is a recent regulatory requirement for novel drugs in general, this requirement does not apply to approved, TB drugs that are off patent and manufactured as generics. Additionally, treatment of adult and pediatric patients may include the administration of TB drugs that are only available as injectable agents. This often requires that the patient be hospitalized to facilitate administration or visit health centers on a daily basis interfering with employment obligations and compromising adherence. Project Goal The goal of this project is to develop improved formulations for currently approved TB drugs for pediatric use and also to develop alternative formulations for drugs currently administered by injection. The final product should be simple to manufacture, stable under ambient conditions, and ready for testing in Phase I bioequivalence and PK studies. NIAID clinical contract resources could be used to facilitate evaluation of these formulations in target populations at the end of the SBIR contract period. Phase I Activities • Development of prototype formulations that address the goals of this solicitation. • Development of analytical assays to characterize chemical composition, purity and stability of prototype formulations. • Assessment of the pharmacokinetic profile and safety of the formulations in an uninfected animal species. • Development or conduct of drug potency assays for bioequivalence studies. Phase II Activities • Scale-up of the formulations (activity need not be compliant with cGMP) for further preclinical studies. • Conduct of additional pharmacology and toxicology evaluations of the formulations in uninfected animals. • Conduct of bioequivalence studies in uninfected animals or infected animals as appropriate.
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