- Adherence to monthly therapies is greater than adherence to weekly and daily therapies
- In developed countries such as the United States, half of patients don’t adhere to medication regimens that must be kept up for more than a couple of days
- Each year in the United States, this problem, called treatment non-adherence, is responsible for $100 billion in health care costs
- Pills deliver medicine the cheap and easy way. But for medication that must be taken daily
- In rich countries, injections, pumps and implanted devices can deliver drugs continuously, but they can be expensive and intrusive. In developing countries, the cost and complexity of such drug-delivery mechanisms can put them out of reach
- Gastric residence dosage form that can be placed in a gelatin capsule to inable oral administration
- Once ingested, it expands and resides in the stomach for extended periods, providing drug release for 3 weeks
- Six polymeric arms joined by an elastomeric core that allows for folding into a capsule to facilitate oral administration. Once the capsule shell has been disolved in the stomach, the dosage form recoils and expands to a larger size than the diameter of the pylorus
- Arms:
- Outer sleeve: made of a rigid polymer that provides mechanical integrity (structural polymer)
- Drug polymer matrix: over the sleeve. It releases drug over extended periods
- Material: PDMS polymer matrices, poly(anhydride)-based matrices, poly(sebacic anhydride)-based matrices for the arms with V-shaped grooves in them. Solid arms made of Sorna 3015G NC010. Central elastomer (Elastollan 1185A10)
- Drug release was affected by the type of polymer matrix and the amount of drug loaded
- For poly(sebacic anhydride) and PDMS matrices, drug release was most rapid at lowest drug loading
- In general, drug release from PDMS matrices was slower than that from poly(sebacic anhydride)-based matrices
- Choice of materials and manufacturing is essential for avoiding disassembling
- Currently the passage of the dose from the stomach is via non-user-controlled mechanisms
- Programmed exist of the dosage form from the stomach may be achieved by inclusion of tough materials that desintegrate in the presence of chemical or thermal stimuli and pH sensitive linkers to maximize safety in the setting of inadverted transit across the pylorus
- Advantages: can be self-administrated, oral, no need for clinical dose removal
- Goal of the original study: develop a gastric resident dosage form that can be orally administered, be retained in the stomach for 1 month and release levonorgestrel (contraceptic drug) in this time
- Device: six arms connected via a central elastomer that allowed for the folding of the dosage form in the capsule and its recoil upon dissolution of the capsule
- The drug was contained by the polymer matrices and these were filled into the cavities of the arm casing of the dosage form