Abstract:
Purpose: The purpose of the present investigation was to improve the flow and mechanical properties of racecadotril
by a crystallo‑co‑agglomeration (CCA) technique. Direct tableting is a requirement of pharmaceutical industries. Poor
mechanical properties of crystalline drug particles require wet granulation which is uneconomical, laborious, and tedious.
Materials and Methods: The objective of this work was to study the influence of various polymers/excipients and
processing conditions on the formation of directly compressible agglomerates of the water‑insoluble drug, racecadotril,
an antidiarrheal agent. The agglomerates of racecadotril were prepared using dichloromethane (DCM)—water as the
crystallization system. DCM acted as a good solvent for racecadotril as well as a bridging liquid for the agglomeration
of the crystallized drug and water as the nonsolvent. The prepared agglomerates were tested for micromeritic and
mechanical properties. Results: The process yielded ~90 to 96% wt/ wt spherical agglomerates containing racecadotril
with the diameter between 299 and 521 μ. A higher rotational speed of crystallization system reduces the size of
the agglomerates and disturbs the sphericity. Spherical agglomerates were generated with a uniform dispersion of
the crystallized drug. CCA showed excellent flowability and crushing strength. Conclusion: Excipients and processing
conditions can play a key role in preparing spherical agglomerates of racecadotril by CCA, an excellent alternative to
the wet granulation process to prepare intermediates for direct compression.
Description:
The authors are grateful to the Gujarat Council on Science and
Technology (GUJCOST), Gandhinagar, Gujarat for providing financial
assistance in this work (MRP‑2015538). They also express their gratitude
to the Evonic Degussa Incorporation, Mumbai, India for providing
samples of Eudragit as a gift
