Abstract: The present invention relates to a pharmaceutical calcium acetate formulation and a process for making the same. In particular, the present invention relates to a calcium acetate capsule formulation comprising granules comprising calcium acetate along with other formulation adjuvants contained within a pharmaceutically acceptable capsule.
Type:
Grant
Filed:
November 14, 2014
Date of Patent:
May 28, 2019
Assignee:
WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED
Abstract: Stable phenobarbital sodium solutions for injection that do not generate impurities during extended storage. These solutions include phenobarbital sodium in an amount of 15 to 200 mg/mL; a C1-C4 alcohol such as ethanol in an amount of 105 to 160 mg/mL; and a glycol such as propylene glycol in an amount of between 620 and 830 mg/mL and have a pH of between 9 and 12 which is adjusted to that range by adding acid or base, as required. No more than 50 mg/mL water is present including any water introduced by the acid or base. The solutions contain no more than 0.8% of phenyl ethyl acetyl urea impurity as well as no detectable amount of phenyl butyric acid after two years storage at room temperature.
Type:
Grant
Filed:
November 18, 2016
Date of Patent:
February 27, 2018
Assignee:
West-Ward Pharmaceuticals International Limited
Inventors:
Michael G. Parker, Scott S. Wilson, Yasmeen Chahal, Kelly W. Hovius, David E. McAnany