title: Dissolution and powder flow characterization of solid self-emulsified drug delivery system (SEDDS).
abstract: In this study, the dynamics of powder flow upon griseofulvin-self-emulsified drug delivery system (SEDDS) addition to silica and silicates and the effect of these adsorbents on drug release were investigated. SEDDS was adsorbed at SEDDS/adsorbent ratios from 0.25:1 to 3:1 on magnesium aluminum silicate [5 and 80 microm], calcium silicate [25 microm], and silicon dioxide [3.6, 20, and 300 microm]. Powder flow was evaluated using the powder rheometer and compared to angle of repose. Release of drug from a 1:1 SEDDS/adsorbent powder was determined by dissolution using USP Type 2 apparatus. Powder rheometer profiles indicated that effect of SEDDS on the flow behavior of the adsorbents could be correlated to stepwise or continuous growing behavior as observed in wet granulation process. However, due to their porous nature, adsorbents exhibited an initial lag phase during which no change in flow was observed. Dissolution of drug from adsorbed-SEDDS was found to be dependent on pore length and nucleation at the lipid/adsorbent interface. Increase in dissolution rate was observed with an increase in surface area and was independent of the chemical nature of the adsorbents. Therefore, in order to manufacture free flowing powder containing liquid SEDDS, special attention should be given to particle size, specific surface area, type and amount of adsorbent.
authors.affiliation: CIMA LABS INC., Brooklyn Park, MN, USA.
authors.forename: Vikas
authors.initials: V
authors.lastname: Agarwal
authors.forename: Akhtar
authors.initials: A
authors.lastname: Siddiqui
authors.forename: Hazem
authors.initials: H
authors.lastname: Ali
authors.forename: Sami
authors.initials: S
authors.lastname: Nazzal
mesh_terms: D000327:Adsorption; D017607:Aluminum Compounds; D000538:Aluminum Silicates / Q000737:chemistry; D000935:Antifungal Agents / Q000737:chemistry*; D017610:Calcium Compounds / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D004655:Emulsions; D005079:Excipients / Q000737:chemistry*; D006118:Griseofulvin / Q000737:chemistry*; D008274:Magnesium / Q000737:chemistry; D017616:Magnesium Compounds; D010316:Particle Size; D011208:Powders; D017640:Silicates / Q000737:chemistry; D012822:Silicon Dioxide / Q000737:chemistry; D012995:Solubility
chemical_list: D017607:Aluminum Compounds; D000538:Aluminum Silicates; D000935:Antifungal Agents; D017610:Calcium Compounds; D004655:Emulsions; D005079:Excipients; D017616:Magnesium Compounds; D011208:Powders; D017640:Silicates; D006118:Griseofulvin; C033065:aluminum magnesium silicate; D012822:Silicon Dioxide; D008274:Magnesium; C031293:calcium silicate