Aqueous oral solution of bisphosphonic acid
AssigneeAurobindo Pharma Ltd
InventorsRamesh Babu Batta, Umesh Nandkumar Khatavkar, Hidaytulla Shamshuddin Aga, Kishor Dattatray Deo, Sivakumaran Meenakshisunderam
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Abstract
The present invention relates to stable aqueous oral formulation of bisphosphonic acid or its pharmaceutically acceptable salts. More particularly, the present invention relates to stable aqueous oral formulation of alendronate sodium. The present invention also relates to a process for the preparation of stable aqueous oral formulation of alendronate sodium.
Claims10
A stable aqueous oral formulation comprising alendronate sodium and inorganic acid, wherein the said formulation has pH in the range of about 2 to 5 and is essentially free of buffers and stabilizers.
A stable aqueous oral formulation comprising about 1% to about 30% by weight of alendronate sodium, an inorganic acid such as dilute hydrochloric acid, dilute sulfuric acid and dilute phosphoric acid;
- about 0.02 to about 2% by weight of preservatives such as methylparaben, ethylparaben, propylparaben and butylparaben;
- about 0.1 to about 2% by weight of sweetening agents such as saccharin sodium, sodium cyclamate, sorbitol, xylitol;
- about 0.05 to about 5% by weight of flavoring agents such as peppermint flavor, spearmint flavor and artificial raspberry flavor, wherein the said formulation has pH in the range of about 2 to 5 and is essentially free of buffers and stabilizers.
A stable aqueous oral formulation comprising
- alendronate sodium
- 50 to 100 mg
- inorganic acid
- 0.0001 to 0.001 mg
- preservatives
- 30 to 80 mg
- sweetening agents
- 20 to 200 mg
- flavoring agents
- 20 to 100 mg
- purified water
- QS to 75 ml,
- wherein the said formulation has pH in the range of about 2 to 5 and is essentially free of buffers and stabilizers.
A process for preparing stable aqueous oral formulation comprising alendronate sodium and inorganic acid, wherein the said formulation has pH in the range of about 2 to 5 and is essentially free of buffers and stabilizers, which comprises the steps of:
- i) dissolving the preservatives in water,
- ii) adding sweetening agent to the solution of step (i),
- iii) adding alendronate sodium to the solution of step (ii),
- iv) adding hydrochloric acid to the solution of step (iii),
- v) adjusting the pH of solution using 0.85% v/v hydrochloric acid,
- vi) adding flavoring agent to the solution of step (v) and
- vii) finally making up the volume with water to obtain a clear solution.
Dependencies are inferred from the claim text.