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strategies to overcmome dose dumping

Solubility of polymer in gastric fluid and the solvent employed for administration of the formulation are to be considered in design of controlled drug delivery systems. The polymer with least solubility in these fluids avoids the possible dose dumping. pH independent polymers and pH dependent polymers soluble in intestinal polymers are preferable to prevent the dose dumping risk. Diffusion controlled systems are preferable compared to dissolution controlled systems go prevent dose dumping. Matrix controlled system are best suited rather than membrane controlled systems.

Dose dumping - technical perspective

Dose dumping is defined as "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 form1." A sustained/extended/controlled release dosage form is intended to release the drug in desired concentrations for a prolonged period of time. A dosage form is said to be dose dumped when there is an excess release of drug at a particular time interval other than the stated or required amount. This results in higher systemic drug concentrations that may result in toxicity.

ICH guideline Q8(R2) – Pharmaceutical development

This guideline suggests looking into the quality of drug product during development stage itself. It says that Quality should be built into the product design rather than testing into products1 during the initial stages of development, all the variables that may likely effect the production or manufacturing process should be completely studied. Those critical variables that are found to be affecting the quality of product must be properly controlled and monitored during the process.

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