Title : Abuse-deterrent dosage form technique utilizing a fusion of innovative pharmaceuticals and ion exchange resin
Abstract:
Prescribed drug abuse denotes the potential misuse of pharmacological formulations. Many regulatory agencies are working to improve rules for current and future drug formulations by using some level of abuse deterrent technologies. Opioids are often and widely misused substances because of their prevalent availability on the market. Prevalent abuse tactics encompass the use of excessive pills or modification of dose types. Regulatory bodies mandate that dosage forms have mechanisms to inhibit these techniques. The physical and chemical alterations include several methods, such as pulverization, inhalation, chemical extraction, and syringe delivery. A self-regulating pharmaceutical dosage form was developed using an ion exchange resin and Tapentadol HCl as a model drug. The formulation was developed by integrating a medication with an ion exchange resin complex and other excipients. This approach produces a robust dose form that withstands many physical and chemical methods employed in drug misuse. The final product underwent water extraction at both standard and elevated temperatures (exceeding 90°C) to evaluate its extraction efficacy. The compressive strength of the combination was validated using both a domestic coffee grinder and a laboratory mortar and pestle. The gelation characteristic of Polyox inhibited the solution's potential for intravenous abuse. The formulation was evaluated using an in vitro dissolution study, as specified in the advice for industry issued by the US Food and Drug Administration (FDA). The study compared the dissolution of a single capsule to that of many capsules (more than four) to validate the abuse-resistant properties of the drug-ion exchange resin-based formulation.
