Pharmaceutical dosage forms comprising valganciclovir hydrochloride

• US 9,642,911 B2
• Filed: 10/31/2014
• Issued: 05/09/2017
• Est. Priority Date: 12/13/2006
• Status: Active Grant

• Current Assignee: Cheplapharm Arzneimittel GmbH
• Original Assignee: Hoffmann-La Roche Incorporated (Roche Holding AG)
• Inventors: Bachynsky, Maria Oksana, Infeld, Martin Howard, Shah, Navnit Hargovindas
• Primary Examiner(s): Ziska, Suzanne
• Assistant Examiner(s): WHEELER, THURMAN MICHAEL
• Application Number:
  US14/529,839
• Publication Number:
  US 20150057296A1
• Time in Patent Office: 921 Days
• Field of Search: None
• CPC Class Codes: A61K 31/522 having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/0095 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 Class Codes: A61K 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/22 for herpes viruses

Abstract

The present invention provides novel solid pharmaceutical dosage forms for oral administration, after being constituted in water. The solid dosage forms comprise a therapeutically effective amount of valganciclovir hydrochloride and a non-hygroscopic organic acid present in an amount sufficient to stabilize the valganciclovir hydrochloride in a predetermined amount of water. The present invention also provides novel liquid pharmaceutical dosage forms for oral administration after constituting the solid pharmaceutical dosage form with water. A non-hygroscopic bulking agent may optionally be included in the above dosage form. These novel pharmaceutical dosage forms are useful in the treatment or control of viruses such as herpes simplex virus and cytomegalovirus. The present invention also provides a method for treating these diseases employing the solid and liquid pharmaceutical dosage forms and a method for preparing these pharmaceutical dosage forms.

Claims

1. A liquid pharmaceutical dosage form for oral administration, wherein the dosage form has the following composition: