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Innovative Oral Formulations for Anti-Infective Drugs

Background
There is a persistent need to develop alternative, simple to administer formulations of FDA approved anti-infective agents for use by children and by adults who have difficulty taking traditional tableted drugs.  These formulations will simplify administration for caretakers and patients and ensure compliance.
There are few child-friendly formulations of pediatric anti-infective medications available to practitioners in the U.S. and especially globally. It is standard practice to cut or crush un-scored adult tablets and administer them to children in juice or other palatable substances, such as food. This practice has significant potential to deliver incorrect and highly variable doses to children, contributing to ineffective treatment. For some adult patients, especially those with difficulty swallowing or those with dementia or other mental impairments, taking standard pills or syrups may be problematic and also affect compliance.
For infectious diseases, completion of drug therapy is critical to assure cure and reduce development of resistance. Resistance often develops when therapy is terminated early or drugs taken intermittently, rather than the prescribed daily doses. Furthermore, for infectious diseases that require long term dosing such as tuberculosis or HIV/AIDS, there is evidence of decrease of patient compliance as time goes on, particularly if drugs are not very palatable. Customized oral formulations are needed that facilitate long term compliance and are of sufficient stability to be suitable for use in resource limited countries.
Examples of the types of oral formulations that may address these issues include, but are not limited to:
?       Oral thin-films
?       Porous, chewable matrix systems (scorable ?Taffy? based on patient weight)
?       Candy-like formulations,  including gummies and jellybeans
It is recognized that these formulations may only be suitable for highly active anti-infective drugs.
While consideration of pediatric applications is a recent regulatory requirement for novel drugs in general, this requirement does not apply to a majority of anti-infective drugs that are already off patent and therefore, development of new formulations should be an attractive commercial goal for small businesses. In addition, offering these easier to take formulations to adults who have difficulty taking oral tablets would further expand the utility of these innovative dosing forms, as well as facilitate overall compliance with taking medicines.
Project Goal
The goal of this project is to develop innovative oral formulations for FDA approved anti-infective agents (antibacterials, antifungals, antiparasitics, and antivirals, including anti-retrovirals for HIV/AIDS) other than nanoparticles or pills to facilitate administration to patients who are either too young or have difficulty taking oral medications.  The final product should be simple to manufacture, stable under ambient conditions and ready for testing in Phase I bioequivalence and PK studies.
Phase I activities include but are not limited to
?       Develop prototype formulations that address the goals of this solicitation
?       Develop analytical assays to characterize the chemical composition, purity and stability of prototype formulations
?       Assess the pharmacokinetic profile and safety of the formulations when delivered in the intended way, in appropriate systems
?       Conduct or develop drug potency assays for bioequivalence studies
PhaseII activities include but are not limited to             
?       Scale-up the formulations (activity need not be compliant with cGMP) for further preclinical studies
?       Conduct additional pharmacology and toxicology evaluations of the formulations in appropriate systems
?       Conduct other pre-clinical studies necessary for subsequent human bioequivalence studies
This SBIR will not support:
 
?       The design and conduct of clinical trials (see https://www.niaid.nih.gov/researchfunding/glossary/pages/c.aspx#clintrial) for the NIH definition of a clinical trial). For SBIR phase II clinical trial support, see the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement.

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