Pharmaceutical compositions of ganciclovir
OwnerRajeev Mathur, Pananchukunnath Kumar +2inventors
InventorsRajeev Mathur, Pananchukunnath Kumar, Sunilendu Roy, Rajiv Malik
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Abstract
The technical field of the invention relates to pharmaceutical compositions of 9-(1,3-dihydroxy-2-propoxymethyl) guanine (ganciclovir) that are stable and contain more than 1% water content. One pharmaceutical composition includes ganciclovir having more than about 1% water content, and one or more pharmaceutically acceptable excipients. The ganciclovir retains at least about 97% of its initial purity after one month, at least about 96% of its initial purity after two months, and at least about 95% of its initial purity after three months when stored at 40° C. and 75% RH. In particular, the water content may be between about 2% and about 6%.
Claims38
A pharmaceutical composition comprising:
- ganciclovir having more than about 1% water content;
- and
- one or more pharmaceutically acceptable excipients,
- wherein the ganciclovir retains at least about 97% of its initial purity after one month, at least about 96% of its initial purity after two months, and at least about 95% of its initial purity after three months when stored at 40° C. and 75% RH.
A process for the preparation of a pharmaceutical composition comprising ganciclovir having a water content of more than about 1% and one or more pharmaceutically acceptable excipients, the process comprising:
- a) blending the ganciclovir having a water content of more than 1% with the one or more pharmaceutically acceptable excipients;
- b) optionally granulating the blend by wet granulation or dry granulation;
- c) lubricating the blend of step a) or the granules of step b);
- and
- d) compressing into or filling into a solid dosage form,
- wherein the ganciclovir retains at least about 97% of its initial purity after one month, at least about 96% of its initial purity after two months, and at least about 95% of its initial purity after three months when stored at 40° C. and 75% RH.
A method of treating infection caused by one or both of cytomegalovirus and herpes simplex virus by administering a pharmaceutical composition to a patient in need thereof, the pharmaceutical composition comprising ganciclovir having more than about 1% water content and one or more pharmaceutically acceptable excipients,
- wherein the ganciclovir retains at least about 97% of its initial purity after one month, at least about 96% of its initial purity after two months, and at least about 95% of its initial purity after three months when stored at 40° C. and 75% RH.
A ganciclovir capsule for oral administration, the ganciclovir capsule comprising:
- ganciclovir having between about 2% and about 6% water content;
- between approximately 80% and approximately 90% w/w ganciclovir;
- between approximately 6% and approximately 8% w/w microcrystalline cellulose;
- between approximately 2% and approximately 4% w/w povidone;
- between approximately 2.5% and approximately 5% w/w croscarmellose sodium;
- and
- between approximately 0.25% and 0.75% w/w magnesium stearate,
- wherein the ganciclovir retains at least about 97% of its initial purity after one month, at least about 96% of its initial purity after two months, and at least about 95% of its initial purity after three months when stored at 40° C. and 75% RH.
Dependencies are inferred from the claim text.