	US 12,364,666 B2
	Stable low digestive enzyme content formulation
Giovanni Ortenzi, Monza (IT); Giuseppe De Franza, Milan (IT); Danilo Clementi, Seriate (IT); Christian Stollberg, Carugate (IT); and Luigi Boltri, Agrate Brianza (IT)
Assigned to Societe des Produits Nestle S.A., Vevey (CH)
Filed by SOCIÉTÉ DES PRODUITS NESTLÉ S.A., Vevey (CH)
Filed on May 23, 2022, as Appl. No. 17/750,648.
Application 17/750,648 is a division of application No. 13/251,926, filed on Oct. 3, 2011, granted, now 11,364,205.
Claims priority of provisional application 61/389,037, filed on Oct. 1, 2010.
Prior Publication US 2022/0280433 A1, Sep. 8, 2022
Int. Cl. A61K 9/20 (2006.01); A61K 9/28 (2006.01); A61K 9/48 (2006.01); A61K 38/46 (2006.01)

CPC A61K 9/2054 (2013.01) [A61K 9/2072 (2013.01); A61K 9/2866 (2013.01); A61K 9/4808 (2013.01); A61K 38/465 (2013.01)]

23 Claims

1. A process for the preparation of a pharmaceutical composition comprising a blend of at least one digestive enzyme and at least one carrier, the process comprising the following steps:

a) mixing the at least one digestive enzyme and the at least one carrier, and optional further excipients;

b) compressing the mixture into beads; and

c) optionally coating the beads with an enteric polymer,

wherein a total amount of the at least one digestive enzyme in the pharmaceutical composition is from 4% to 19% by weight, and the at least one carrier comprises microcrystalline cellulose having an average particle size greater than 100 μm.