
Some drugs cannot be formulated as controlled release dosage forms because of poor solubility, degradation in the alkaline media, or presence of specific transport mechanism in the small intestine. This leads to the presence of a 'window' or 'narrow zone' of absorption. Our Gastro Retentive Innovative Device (GRID) is designed to offer longer retention times in the stomach, of about eight hours, for such drugs.
This innovative system is a dosage form with specialized multiple coatings. On ingestion of the dosage form along with food, it floats instantaneously on the gastric contents. GRID's coatings are activated by gastrointestinal fluid, eventually leading to swelling, to about eight to eleven times its initial volume.
During the cycle of intense gastric movements, GRID retains its shape and form so as to release medication in a controlled fashion. Plasma concentrations for medicines are thus maintained in the therapeutic range for a prolonged period; hence this dosage form can be used as a "Once-a- day" system.
Specific release profiles for drugs can be tailored to achieve combination of immediate and slow release using this innovative dosage form. Retention of the dosage form close to its site of absorption may help in reducing the dose and thus the side effects.
Based on the GRID technology, Baclofen ER has been developed to treat muscle spasticity due to cerebrovascular accidents, cerebral palsy, multiple sclerosis, spinal lesions, head injury, etc. There has been a good switchover from the three times a day immediate release formulation to the GRS formulation with effective symptom control and lower sedation. For India, phase 1, 2 and 3 have been completed and the product is approved. For the US, preparations for the IND filing are ongoing. |