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Production of extended release mini-tablets using directly compressible grades of HPMC

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Background: Hypromellose (HPMC) has been utilized previously to regulate drug release in mini-tablets. However, due to suboptimal flow characteristics, the production of mini-tablets with elevated HPMC levels presents a challenge. The Dow Chemical Company has introduced directly compressible (DC) HPMC grades. Objective: To compare the characteristics of HPMC DC (METHOCEL™ K4M and K100M) with regular (REG) HPMC grades. Methodology: Assessment of particle size distribution and flowability of HPMC REG and DC. Generation of 3 mm mini-tablets, incorporating hydrocortisone or theophylline as model drugs and 40% w/w HPMC DC or REG. Production of mini-tablets containing HPMC DC grades using a rotary press simulator at forces between 2–4 kN and speeds of 5, 10, 15, or 20 rpm, while HPMC REG mini-tablets were manually produced. Results and Discussion: The enhanced flowability of HPMC DC grades, characterized by a narrower particle size distribution and larger particle sizes, facilitated the simulated large-scale production of mini-tablets with satisfactory weight uniformity (CV 1.79–4.65%). Automatic manufacturing of mini-tablets containing HPMC REG was impractical due to the poor flowability of the formulations. Drug release from mini-tablets comprising HPMC DC and REG exhibited comparability. Mini-tablets containing HPMC DC demonstrated higher tensile strength compared to those made with HPMC REG. Mini-tablets produced with HPMC DC at different compression speeds displayed similar drug release profiles. Conclusions: Successful production of extended-release mini-tablets was achieved with the use of HPMC DC. The drug release rate was not affected by the different HPMC DC grades (K4M or K100M) or production speed.
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