Crystallized oxalate decarboxylase and methods of use
Oxalate decarboxylase crystals, including stabilized crystals, such as cross-linked crystals of oxalate decarboxylase, are disclosed. Methods to treat a disorder associated with elevated oxalate concentration using oxalate decarboxylase crystals are also disclosed. Additionally disclosed are methods of producing protein crystals.
1. A pharmaceutical composition comprising spray-dried biologically active oxalate decarboxylase crystals having a moisture content of less than 5% by weight, wherein the oxalate decarboxylase is uncrosslinked and is capable of converting oxalate to formate.
2. The pharmaceutical composition of claim 1 , wherein the oxalate decarboxylase crystals are about 1 μm to about 25 μm in length.
3. The pharmaceutical composition of claim 1 , further comprising at least one excipient selected from a sugar, sugar alcohol, viscosity increasing agent, wetting agent, solubilizing agent, buffer salt, emulsifying agent, antimicrobial agent, and an antioxidant.
4. The pharmaceutical composition of claim 1 , wherein the composition is an oral dosage form.
5. The pharmaceutical composition of claim 4 , wherein the oral dosage form is formulated as a capsule.
6. The pharmaceutical composition of claim 4 , wherein the oral dosage form is formulated as a tablet.
7. The pharmaceutical composition of claim 1 , wherein the oxalate decarboxylase retains at least 50% of its activity upon exposure to an aqueous solution having a pH of about 6.8 for 1 hour.
8. The pharmaceutical composition of claim 1 , wherein the oxalate decarboxylase is a recombinant oxalate decarboxylase.
9. The pharmaceutical composition of claim 1 , wherein the oxalate decarboxylase has an amino acid sequence which has at least 95% sequence identity with SEQ ID NO: 3.