A review on abuse-deterrent formulations: formulation technology and regulatory stands in approval process

Author:

Bhola Jaydip1ORCID,Borkhataria Chetan2ORCID

Affiliation:

1. Department of Pharmaceutics, Gujarat Technological University, Ahmedabad, India

2. Department of Pharmaceutics, B. K. Mody Government Pharmacy College, Rajkot, India

Publisher

Informa UK Limited

Reference52 articles.

1. Alpharma Pharmaceuticals/King Pharmaceuticals. 2009a. EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules [Chemistry review]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022321s000ChemR.pdf.

2. Alpharma Pharmaceuticals/King Pharmaceuticals. 2009b. EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules [Summary review]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022321s000SumR.pdf.

3. Abuse-deterrent properties and cytotoxicity of poly(ethylene oxide) after thermal tampering

4. Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

5. CDER-USFDA. 2010. OxyContin (Oxycodone Hydrochloride) Controlled-Release Tablets [Summary review]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000SumR.pdf.

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