Solid pharmaceutical dosage form suitable for use as drinking water medication

Patent metadata

Field	Value
Publication number	US-10335371-B2
Application number	US-201615551636-A
Country	US
Kind code	B2
Filing date	Feb 17, 2016
Priority date	Feb 17, 2015
Publication date	Jul 2, 2019
Grant date	Jul 2, 2019

Abstract

The present invention relates to solid pharmaceutical dosage forms suitable for use as drinking water medication. More in particular, the present invention provides solid pharmaceutical dosage forms comprising a pharmaceutically active agent, a non-ionic surfactant having an Hydrophilic Lipophilic Balance (HLB) of at least 8, and a maltodextrin. The present invention also provides the use of such pharmaceutical dosage forms in veterinary medicine, more in particular as drinking water medication; as well as methods for preparing such pharmaceutical dosage forms.

First claim

The invention claimed is:

1. A method for the preparation of a spray-dried solid pharmaceutical multiparticulate dosage form, the method comprising:
preparing a suspension comprising a pharmaceutical non-solubilized active ingredient, a non-ionic surfactant having an Hydrophilic Lipophilic Balance (HLB) of at least 8 and water;
milling the suspension;
adding a maltodextrin to the milled suspension; and
spray-drying the milled suspension.

2. The method according to claim 1 , wherein:
the non-ionic surfactant has an HLB of 8 to 20; and
the pharmaceutical non-solubilized active ingredient is selected from the group consisting of antibiotics, anticoccidials, and non-steroidal anti-inflammatory drugs.

3. The method according to claim 1 , wherein the pharmaceutical non-solubilized active ingredient is a poorly water-soluble active agent.

4. The method according to claim 1 , wherein the pharmaceutical non-solubilized active ingredient is selected from the group consisting of pyrimidine antibacterial chemotherapeutics, macrocylic lactones, anticoccidials, and non-steroidal anti-inflammatory drugs.

5. The method according to claim 1 , wherein the non-ionic surfactant is a polysorbate selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, and polysorbate 80.

6. The method according to claim 1 , wherein the maltodextrin is selected from the group consisting of maltodextrin with a Dextrose Equivalent (DE) of 9, maltodextrin with a DE of 14, and maltodextrin with a DE of 18.

Assignees

• Univ Gent
• Orotech Nv

Inventors

• Remon Jean-Paul
• Vervaet Chris
• Vermeulen Brenda

Classifications

• A23K10/00

  Animal feeding-stuffs · CPC title

• A23K20/121

  containing oxygen or sulfur as hetero atom · CPC title

• A23K20/163

  Sugars; Polysaccharides · CPC title

• A61K9/0095

  Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006) · CPC title

• A23K50/75

  for poultry · CPC title