Pharmaceutical composition with improved stability
OwnerYuhua Li, Andrew J. Guarinoinventors
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Abstract
The present invention provides an injectable composition for controlled release drug delivery and the process of making the same, where the composition comprises: a lactate-based polymer having a weight average molecular weight between 5,000 and 50,000 dalton, an acid number of less than 3 mgKOH/g and the content of residual lactide monomers in the lactate-based polymer of less than about 0.3% by weight; a pharmaceutically acceptable organic solvent; and a bioactive substance or a salt thereof that contains an amino acid serine in the molecular structure that is capable of reacting with lactide monomer to form a conjugate; and where the composition reduces the formation of the conjugate.
Claims22
A process for making an injectable composition for controlled release drug delivery comprising:
- combining a lactate-based polymer having a weight average molecular weight between 5,000 and 50,000 dalton, an acid number of less than 3 mgKOH/g and the content of residual lactide monomers in the lactate-based polymer of less than about 0.3% by weight;
- with
- a pharmaceutically acceptable organic solvent;
- and
- a bioactive substance or a salt thereof that contains an amino acid serine in the molecular structure that is capable of reacting with lactide monomer to form a conjugate,
- with the proviso that no acid additive is added in making the composition.
An injectable composition for controlled release drug delivery comprising:
- a. a lactate-based polymer having a weight average molecular weight between 5,000 and 50,000 dalton, an acid number of less than 3 mgKOH/g and the content of residual lactide monomers in the lactate-based polymer of less than about 0.3% by weight;
- b. a pharmaceutically acceptable organic solvent;
- and
- c. a bioactive substance or a salt thereof that contains an amino acid serine in the molecular structure that is capable of reacting with lactide monomer to form a conjugate,
- with the proviso that no acid additive is added in producing the composition, and the composition reduces the formation of the conjugate.
The injectable composition of claim 13 where the lactide in the lactate-based polymer is D-lactide, D,L-lactide, L,D-lactide, L-lactide, (R,R)-Lactide, (S,S)-lactide and meso-lactide or any combination thereof.
Dependencies are inferred from the claim text.