CPC A61K 38/29 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2013 (2013.01); A61K 9/2095 (2013.01); A61K 9/2806 (2013.01); A61K 47/18 (2013.01); A61P 19/08 (2018.01); A61P 19/10 (2018.01); A61K 9/0056 (2013.01)] | 30 Claims |
1. A pharmaceutical composition multi-unit dosage form comprising at least three discrete unit dosage forms bound to one another by a coating and/or matrix, each of said unit dosage forms comprising a therapeutically active agent and an absorption enhancer, said therapeutically active agent having a molecular weight in a range of 1 kDa to 100 kDa and/or being a BCS Class III agent, said unit dosage forms together comprising a therapeutically effective amount of said therapeutically active agent and an effective amount of said absorption enhancer, wherein said coating and/or matrix is formulated for immediate release of said unit dosage forms upon oral administration, such that the multi-unit dosage form disintegrates in gastric fluid and/or in saliva within no more than 5 minutes to thereby release said unit dosage forms, wherein said absorption enhancer is selected from the group consisting of NAC (8-N-(2-hydroxybenzoyl)aminocaprylate), NAD (10-N-(2-hydroxybenzoyl)aminodecanoic acid), 5-CNAC (8-N-(5-chlorosalicyloyl)aminocaprylic acid), 4-MOAC (8-N-(2-hydroxy-4-methoxybenzoyl)aminocaprylic acid), 4-CNAB (4-N-(2-hydroxy-4-chlorobenzoyl)aminobutanoic acid) and salts thereof, and wherein at least 50 weight percents of the unit dosage forms consists of said absorption enhancer.
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