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US 2006/0233878 A1Published application
Extended release formulation of beta-lactam antibiotics
AssigneeLupin Limited
InventorsShailesh Bhamare, Indu Bhushan, Himadri Sen
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AssigneeLupin Limited
InventorsShailesh Bhamare, Indu Bhushan, Himadri Sen
Estimating the term…
A pharmaceutical composition for controlled drug delivery comprising a β-lactam antibiotic or its pharmaceutically acceptable hydrates, salts or esters, and one or more carbomers. The above β-lactam antibiotics formulation avoids the limitations of known β-lactam controlled release form which are found to be either complex and/or cost-extensive to obtain requiring multiphase and/or selective coatings or fail to achieve the desired controlled release for once daily dosage form. Importantly, in the β-lactam antibiotic form of the above the rate-controlling polymer wherein the Cmax of the formulation is substantially the same as that of a single dose of the immediate release formulation. Also advantageously the formulation achieves a rate controlling polymer wherein the T>MIC for the formulation is more than 17 hours when the MIC is 0.25 mcg/ml and more than 10 hours when the MIC is 2 mcg/ml. The above β-lactam antibiotic form is thus directed to serve as the much desired simple and cost-effective controlled release form suitable for once daily administration.
A pharmaceutical composition for controlled drug delivery comprising a β-lactam antibiotic and one or more carbomers.
The process for the preparation of the pharmaceutical composition comprising mixing together, a β-lactam antibiotic or their pharmaceutically acceptable hydrates, salts or esters;
A controlled release composition of β-lactam antibiotic comprising a pharniaceutically effective amount of β-lactam antibiotic, one or more carbomers, a water-soluble and/or water dispersible diluent and pharmaceutically acceptable tablet excipients for controlling the release of β-lactam antibiotic.
A controlled release composition comprising a β-lactam antibiotic and a release controlling polymer wherein the Cmax is substantially the same as that of a single dose of an immediate release formulation.
A controlled release composition comprising a β-lactam antibiotic and a release-controlling polymer wherein the T>MIC at 0.25 mcg/ml was achieved for about 75% of the dosing interval and T>MIC of 2 mcg/inl was achieved for almost 49% of the dosing interval.
A controlled release composition comprising from about 30-90% w/w of cefprozil and from about 0.1-50% by weight of one or a mixture of carbomers and optionally one or more pharmaceutically acceptable excipients selected from amongst diluents and lubricants.
Dependencies are inferred from the claim text.