title: Investigating critical effects of variegated lubricants, glidants and hydrophilic additives on lag time of press coated ethylcellulose tablets.
abstract: The research envisaged focuses on vital impacts of variegated lubricants, glidants and hydrophilic additives on lag time of press coated ethylcellulose (EC) tablets using prednisone as a model drug. Several lubricants and glidants such as magnesium stearate, colloidal SiO2, sodium stearyl fumarate, talc, stearic acid, polyethylene glycol (6000) and glyceryl behenate were investigated to understand their effects on lag time by changing their concentrations in outer coat. Further, the effects of hydrophilic additives on lag time were examined for hydroxypropylmethylcellulose (E5), hydroxypropylcellulose (EF and SSL), povidone (K30), copovidone, polyethylene glycol (4000), lactose and mannitol. In vitro drug release testing revealed that each selected lubricant/glidant, if present even at concentration of 0.25% w/w, significantly reduced the lag time of press coated tablets. Specifically, colloidal SiO2 and/or magnesium stearate were detrimental while other lubricants/glidants were relatively less injurious. Among hydrophilic additives, freely water soluble fillers had utmost influence in lag time, whereas, comparatively less impact was observed with polymeric binders. Concisely, glidant and lubricant should be chosen to have minimal impact on lag time and further judicious selection of hydrophilic additives should be exercised for modulating lag time of pulsatile release formulations.
authors.affiliation: a Pharmacy Department, Faculty of Technology and Engineering , The Maharaja Sayajirao University of Baroda , Kalabhavan , Vadodara , Gujarat , India.
authors.forename: Riddhish
authors.initials: R
authors.lastname: Patadia
authors.affiliation: a Pharmacy Department, Faculty of Technology and Engineering , The Maharaja Sayajirao University of Baroda , Kalabhavan , Vadodara , Gujarat , India.
authors.forename: Chintan
authors.initials: C
authors.lastname: Vora
authors.affiliation: a Pharmacy Department, Faculty of Technology and Engineering , The Maharaja Sayajirao University of Baroda , Kalabhavan , Vadodara , Gujarat , India.
authors.forename: Karan
authors.initials: K
authors.lastname: Mittal
authors.affiliation: a Pharmacy Department, Faculty of Technology and Engineering , The Maharaja Sayajirao University of Baroda , Kalabhavan , Vadodara , Gujarat , India.
authors.forename: Rajashree
authors.initials: R
authors.lastname: Mashru
mesh_terms: D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D005079:Excipients / Q000737:chemistry*; D057927:Hydrophobic and Hydrophilic Interactions; D065347:Hypromellose Derivatives / Q000737:chemistry; D007785:Lactose / Q000737:chemistry; D054327:Lubricants / Q000737:chemistry*; D008353:Mannitol / Q000737:chemistry; D011092:Polyethylene Glycols / Q000737:chemistry; D011205:Povidone / Q000737:chemistry; D011241:Prednisone / Q000737:chemistry; D012822:Silicon Dioxide / Q000737:chemistry; D012995:Solubility; D013229:Stearic Acids / Q000737:chemistry; D013607:Tablets / Q000737:chemistry*
chemical_list: D005079:Excipients; D054327:Lubricants; D013229:Stearic Acids; D013607:Tablets; D065347:Hypromellose Derivatives; D008353:Mannitol; D011092:Polyethylene Glycols; C031183:stearic acid; D012822:Silicon Dioxide; C013517:ethyl cellulose; D002482:Cellulose; C008079:hydroxypropylcellulose; D011205:Povidone; D007785:Lactose; D011241:Prednisone
keywords: Chronotherapeutic; compression coating; excipient; pulsatile release formulation