<p class="abstract"><strong>Background:</strong> This <em>in vitro</em> study compared physical parameters and the dissolution profile of innovator itraconazole capsule formulation, i-Tyza, and 5 other generic capsule formulations available in the Indian market.</p><p class="abstract"><strong>Methods:</strong> The number of pellets and size distribution were determined using naked eye examination and sieving method, respectively. Dissolution profile of formulations was done at 15, 30, 45, and 60 minutes, using a United States Pharmacopeia type II Paddle apparatus in simulated gastric fluid (SGF, pH 1.2) without enzymes, acetate buffer (pH 4.5) with 0.5% sodium lauryl sulfate (SLS), and phosphate buffer (pH 6.8) with 0.5% SLS.<strong></strong></p><p class="abstract"><strong>Results:</strong> All formulations had capsule size 0. Capsule fill weight (~335 to ~510 mg) and total pellet number (127 to 810) varied across formulation, with the innovator brand having the highest number of pellets. Innovator product and i-Tyza had similar fill weight (~460 mg). Pellet size distribution of the innovator product, brand 2, brand 3, and i-Tyza was relatively narrow. In SGF, except brand 1 (84% dissolved) and brand 5 (80% dissolved), all the formulations had near-complete (&gt;85% drug dissolved) or complete dissolution (&gt;90% drug dissolved) at 60 minutes. In acetate buffer, pH 4.5 with 0.5% SLS and phosphate buffer, pH 6.8 with 0.5% SLS, only the innovator product and i-Tyza demonstrated near-complete to complete dissolution at 60 minutes (96% and 90% dissolved).</p><p class="abstract"><strong>Conclusions:</strong> Across all the itraconazole generic formulations evaluated, i-Tyza had comparable physical characteristics and dissolution profile to the innovator product. The <em>in vitro</em> dissolution profile of i-Tyza may indicate adequate <em>in vivo</em> performance.</p>

Background: Alginate-based, raft-forming antacid products with reflux suppressant activity are complex formulations expected to achieve effective raft formation and cause elimination or displacement of the acid pocket, which is typically manifested in gastroesophageal reflux disease (GERD).Methods: In the present study, six alginate-based raft-forming products commercially available in the Indian market were compared in terms of their acid neutralization properties, strength, resilience and structural and thermal properties of their rafts. Percent alginate content was also determined.Results: Rafts of products containing calcium-based antacids formed voluminous, porous and floating rafts within seconds of addition to the simulated gastric fluid (SGF) compared with the products that contained aluminium and magnesium-based antacids. Marked differences were not evident in the ANC (acid neutralization capacity) values of the various products. No correlation was observed between ANC and raft-forming capacity or duration of neutralization. Raft structures affected their neutralization profiles. Rafts of porous and absorbent nature could retain their ANC probably due to release of trapped antacids. Further, raft strengths of only two products were above the British Pharmacopoeia specification of not less than 7.5 g. Sodium alginate content was within specifications (85-115%) for three of the six products.Conclusions: Raft-forming formulations with higher alginate content and calcium-based antacids have better physicochemical properties such as ANC, neutralization profiles, raft strength and raft resilience than those with lower alginate content or those containing aluminium or magnesium-based antacids.