Abstract
Background: Paracetamol is one of the most commonly used active ingredients, even without a doctor's prescription for most people. It has effects on relieving pain and treating fever, especially with an analgesic effect for the elderly who have to suffer from degenerative joint disease. However, the half-life of paracetamol is relatively short, from 1 to 3 hours, so patients need to use it many times a day. The use of large amounts of paracetamol for a long time constantly can cause irreversible liver damage, so the prolonged release dosage form is chosen for the following reasons. Not only does it maintain the therapeutic drug concentration, and help reduce the number of use times but it also limits unwanted side effects. Objectives: the dissolution and the release kinetics of the active ingredient of the reference tablet Tylenol 8 Hour 650 mg were surveyed in order to formulate the paracetamol 650mg prolonged release tablet and there was an in vitro equivalent evaluation between the prepared paracetamol 650mg prolonged release tablet and the reference tablet Tylenol 8 Hour 650 mg. Materials and methods: an active ingredient (paracetamol); excipients are used in double-layer formulations that include an immediate release layer and a sustained release one; an experimental study that used a wet granulation method was conducted on a rotary tablet press. Results: the formulation of paracetamol 650 mg prolonged release tablets with f2, compared with the reference tablets Tylenol 8 Hour 650 mg in all three media with pH of 1.2, 4.5, and 6.8, was greater than 50. Conclusions: the result of the study is one of the most essential bases in order to upgrade to a pilot scale, gradually develop to an industrial scale, test in vivo equivalence, and then bring products with well-made quality and safety to consumers as well as patients.
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