Delivery Platform for the Modified and/or Controlled Release of Solid, Oral Dosage Formulations of Drugs
Flamel’s Micropump platform permits either extended, or both delayed and extended, delivery of small molecule drugs via the oral route. It is particularly suitable for drugs with a narrow window of absorption in the upper part of the small intestine.
Micropump consists of a multiple-particulate system containing 5,000 to 10,000 microparticles per capsule or tablet.
The 200-500 microns diameter-sized microparticles are released in the stomach and pass into the small intestine, where each microparticle, operating as a miniature delivery platform, releases the drug at an adjustable rate and over an extended period of time.
Various dosage forms:
Micropump’s Key Attributes
- extended transit time in the small intestine with a mean plasma residence time extended up to 24 hours, which is especially suitable for short-lived drugs known to be absorbed only in the small intestine;
- the microparticles’ design can be potentially adapted to each drug’s specific characteristics by modifying the coating thickness and composition for improved efficacy, reduced toxicity and/or side effects, and improved patient compliance (once-a-day regimen);
- extremely precise pharmacokinetic profiles: extended (and/or delayed) release of single or combination of drugs, in a variety of formats (tablet, capsule, sachet, or liquid), while preserving the targeted release rate over the shelf-life of the product;
- controlled-release of poorly soluble (< 0.01mg/L) as well as highly soluble (> 500g/L) chemical drugs;
- Applicable to low dose (below 4 mg) or high dose (1,000 mg) chemical drugs;
- Good tolerability;
- Avoids dose dumping;
- Reduces intra- and inter-variability; and,
- Good mouth feel and taste masking.