Biopharmaceuticals food, effect

S. Shelukar, G Kwei, and D. Storey (2004). The role of biopharmaceutics in the development of a clinical nanoparticle formulation of MK-0869 a beagle dog model predicts improved bioavailability and diminished food effect on absorption in humlait). J. Pharm, 285 135-146. 

The primary goal during candidate screening is to rank order a large number of compounds based on efficacy in animal models, biopharmaceutical properties (such as solubility and permeability in caco-2 cells, maximum absorbable dose, potential of food effect, etc.), preliminary pharmacokinetic profile in animals, and potential for metabolic and toxicity liabilities. A non-GLP Ames test may be performed to screen for potential mutagenicity. 

Early analytical activities focus on becoming familiar with the chemistry, physical properties, and stability of the new APIs. The purity of the test material(s) and preliminary solid-state and solution stability should be established for candidates prior to use in the Ames test. Candidates are also screened with respect to potential technical issues for further development. Purity and stability testing are performed using a combination of relatively simple chromatographic methods (i.e., HPLC, TLC, GC). A basic solubility profile is developed. Preliminary solid-state characterization is performed using DSC, TGA, and XRD. Early selection of a pharmaceutically acceptable chemical form (where applicable) becomes a key activity to ensure optimal bioavailability (BA), stability, and manufacturability. Biopharmaceutical properties such as potential of food effect, particle size effect, etc., of the proposed clinical candidates are assessed by in vitro and in silico methods. 

Considering the critical role of plant-based food to cover the future food demand by a rapidly growing worldwide population, a better knowledge of plant proteins (composition, interactions, adverse effects, allergic reactions, and biopharmaceutical discoveries) becomes a strategic challenge. 

Since oral administration is the most common and useful, there are many opportunities in developing oral dosage forms. The oral route faces several obstacles to drug absorption, such as the first pass effect, individual variabihty of bioavailability, and drug-induced local irritation to gastric and intestinal mucosa. According to the US Food and Drug Administration (FDA) Biopharmaceutics Classification System... 

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