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SRC files patent for “Bioenhanced Formulations”

 

The invention relates to a pharmaceutical composition comprising a poorly water soluble active ingredient, at least one solubilizer and at least one pharmaceutically acceptable excipient, and a process for manufacturing the same.

Aqueous solubility of any therapeutically active substance is a key property as it governs dissolution, absorption and thus the in vivo efficacy. Poorly water soluble compounds have solubility and dissolution related bioavailability problems. The dissolution rate is directly proportional to the solubility of drugs. Drugs with low aqueous solubility have low dissolution rates and hence suffer from oral bioavailability problems. The poor solubility and poor dissolution rate of poorly water soluble drugs in the aqueous gastro intestinal fluids often cause insufficient bioavailability. Other in-vivo consequences due to poor aqueous solubility include increased chances of food effect, more frequent incomplete drug release from the dosage form and higher inter-patient variability.

Improvement in solubility of a poorly water soluble drug would increase gastrointestinal absorption of the drug thereby increasing the bioavailability which may result in reduction of dose. Further this would also decrease food effect and inter-patient variability. In effect, this would result in improving the therapeutic efficacy and increase patient compliance.

Nearly 40% of the new chemical entities currently being discovered are poorly water soluble drugs. Thus, there is a greater need to develop a composition, which provides enhanced solubility of the poorly soluble drugs and increases its dissolution rate and thus improves its bioavailability to provide a formulation with reduced dose and better therapeutic efficacy and as a result overcomes the drawbacks presented by the prior art.

The invention relates to a pharmaceutical composition comprising a poorly water soluble active ingredient, at least one solubilizer and at least one pharmaceutically acceptable excipient, and a process for manufacturing the same.

 

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