Abstract
Hot-melt extrusion (HME) has been extensively investigated for continuous manufacturing of amorphous solid dispersions, to improve the solubility of poorly water-soluble drug substances, impart abuse deterrence to controlled substances, taste masking for pediatric and geriatric formulations and development of cocrystal system. Much research has been conducted on the continuous manufacturing of solid dosage forms using HME, but its applicability in the manufacturing of semisolids remains an unexplored domain. This study aimed to explore the applicability of HME in the continuous manufacturing of topical semi-solid formulations with two active pharmaceutical ingredients (APIs). Ointments containing a combination of triamcinolone acetonide and lidocaine hydrochloride were screened based on a quality target product profile (QTPP) and established critical quality attributes (CQAs) using design of experiments (DoE). Three selected formulations, manufactured by a lab-scale fusion method and HME, were subjected to further characterization studies including work of adhesion, stiffness, apparent pH, content uniformity, differential scanning calorimetry, accelerated stability, and in vitro drug release testing. Selected formulations met d...Continue Reading
References
Mar 1, 1995·Pharmaceutical Research·G L AmidonJ R Crison
Nov 4, 1998·Journal of Pharmaceutical and Biomedical Analysis·P R RegeC C Collins
Jun 22, 2005·Journal of Pharmaceutical and Biomedical Analysis·Rajan K Verma, Sanjay Garg
Sep 25, 2007·Drug Development and Industrial Pharmacy·Michael M CrowleyCharles Martin
Oct 27, 2007·Drug Development and Industrial Pharmacy·Michael A RepkaJames W McGinity
Jan 11, 2008·Pharmaceutical Research·Lawrence X Yu
Sep 16, 2010·AAPS PharmSciTech·Shiow-Fern NgGillian M Eccleston
Dec 7, 2010·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Javier O Morales, Jason T McConville
Apr 5, 2011·International Journal of Pharmaceutics·Juergen Siepmann, Nicholas A Peppas
Nov 24, 2011·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Mohammed ManiruzzamanDennis Douroumis
Jul 26, 2012·ISRN Pharmaceutics·Ketan T SavjaniJignasa K Savjani
Nov 28, 2012·International Journal of Pharmaceutics·Sejal ShahMichael A Repka
Apr 11, 2013·The AAPS Journal·Rong-Kun ChangLawrence Yu
Jun 15, 2013·Drug Development and Industrial Pharmacy·Mohammed ManiruzzamanDennis Douroumis
Aug 7, 2013·International Journal of Pharmaceutics·Ariana Qiao Jun LowSui Yung Chan
Aug 13, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Elena ReitzMarkus Thommes
Jul 1, 2012·Drug Discovery Today. Technologies
Jan 18, 2014·The Journal of Pharmacy and Pharmacology·Sindhuri MaddineniMichael A Repka
Apr 19, 2015·International Journal of Pharmaceutics·Manjeet B PimparadeMichael A Repka
Jul 25, 2015·AAPS PharmSciTech·Nicole JedingerEva Roblegg
Aug 21, 2015·AAPS PharmSciTech·Abhishek JuluriS Narasimha Murthy
Dec 3, 2015·AAPS PharmSciTech·Ajinkya M BhagurkarMichael A Repka
Nov 20, 2016·International Journal of Pharmaceutics·Esra'a AlbarahmiehDuncan Q M Craig
Jan 22, 2017·AAPS PharmSciTech·Jaywant PawarVaishali Tawde
Dec 19, 2017·International Journal of Pharmaceutics·Nicole S MendonsaMichael A Repka
Feb 17, 2018·AAPS PharmSciTech·Anton J P van HeugtenH Vromans
Jan 14, 2020·International Journal of Pharmaceutics·Rishi ThakkarMichael A Repka