Formulation design for orally disintegrating tablets containing enteric-coated particles

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Materials Science

Background:

• Orally disintegrating tablets (ODTs) offer improved patient compliance for oral drug administration.
• Incorporating enteric-coated particles into ODTs presents challenges in maintaining particle integrity during tableting.
• Controlled-release formulations require robust technologies to ensure consistent drug release profiles.

Purpose of the Study:

• To evaluate the applicability of RACTAB® technology for manufacturing ODTs containing enteric-coated particles.
• To assess the impact of the tableting process on the integrity and functionality of enteric-coated tamsulosin hydrochloride particles.
• To characterize the physical and functional properties of the developed ODTs.

Main Methods:

• Preparation of enteric-coated tamsulosin hydrochloride particles (ECP-T) via spray coating.
• Formulation of ODTs (ODTRAC) by combining ECP-T with rapidly disintegrating granules (RDGs).
• Evaluation of ODTRAC properties including hardness, friability, internal structure (X-ray-CT), in vitro dissolution, and in vivo disintegration time.

Main Results:

• ODTRAC tablets exhibited high hardness (>50 N) and low friability (<0.5%) due to RDGs containing micronized ethylcellulose.
• X-ray-CT scanning confirmed the structural integrity of ECP-T within ODTRAC after tableting.
• Recovered ECP-T maintained the original dissolution profile, indicating no loss of acid-resistibility; in vivo disintegration was rapid (<30 s).

Conclusions:

• RACTAB® technology is a viable method for producing ODTs containing enteric-coated particles.
• The technology preserves the integrity and controlled-release characteristics of enteric-coated particles during ODT manufacturing.
• The developed ODTRAC formulation demonstrates excellent physical properties and rapid in vivo disintegration.