Unintended, rapid drug release in a short period of time of the entire amount or a significant fraction of the drug contained in a modified release dosage form is often referred to as “dose dumping”. Depending on the therapeutic indication and the therapeutic index of a drug, dose-dumping can pose a significant risk to patients, either due to safety issues or diminished efficacy or both. Generally dose-dumping is observed due to a compromise of the release-rate-controlling mechanism. The likelihood of dose-dumping for certain modified release products when administered with food has been recognized for about twenty years and a regulatory process established to address it.
The proposed co-processed excipient, is manufactured using GRAS pharmacetical excipients and is easy to manufactured even at production scale. More advantageous is its application in aqueous medium makes its Eco-friendly.
Description of the technology
Dose dumping is most commonly seen in drugs taken by mouth and digested in the gastrointestinal tract. Around the same time patients take their medication, they can also ingest other substances like fatty meals or alcohol that increase drug delivery. The substances may act on the drug's dosage form to speed up drug release, or they may stimulate the body's absorptive surfaces to increase the rate of drug uptake. We have developed the co-processed ready mix coating excipient system which can avoid the dose dumping and minimize the adverse toxic effects.
Specifications
Pharmaceutical excipient is an integral part of the formulation. It covert the potent drug product/s in to deliverable formulation. The handling and maintainability of the inventory for excipient is one of the big challenge for pharma companies. Thus its need of hour to have simple co-processed excipient. The proposed co processed excipient is easy to handle and manufacture co-processed excipient, ready mix excipient, made up of regular pharmacetical GRAS excipients.
Main advantages of its use
Applications
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