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US 2020/0268651 A1Published application
Stable vitamin b12 liquid formulations
OwnerHemant N. Joshi, Neelam Sharmainventors
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Abstract
An aqueous solution of vitamin B12 can be stabilized by the synergistic effect of HPMC, carrageenan and potassium acetate. This property is used to develop four formulations—1. A solution used to prepare B12 loaded capsule shell matrix, 2. vitamin B12 injectable formulation, 3. vitamin B12 nasal formulation and 4. Vitamin B12 oral solution formulation.
Claims20
A composition of a liquid used for the preparation of a stable slow-release vitamin B12 orally dissolvable empty capsule shell matrix comprising:
- (i) a therapeutic dose of vitamin B12;
- (ii) synergistic amounts of a hard shell-forming material, carrageenan and potassium acetate;
- (iii) purified water;
- and (iv) pharmaceutical acceptable excipients;
- wherein the capsules are prepared under long wavelength light and optionally under nitrogen over-lay;
- wherein the said capsule shell matrix is prepared using a pin-dip method;
- wherein optionally a drug(s) known to impair absorption of vitamin B12 is filled inside the core of said capsule.
4 more elements
A stable injectable composition of vitamin B12 comprising:
- (i) a therapeutic dose of vitamin B12;
- (ii) optionally a buffer to adjust the pH of the formulation between 4.5 and 7.5:
- (iii) sodium chloride;
- (iv) synergistic amounts of a polymer, carrageenan and potassium acetate;
- (v) hydrochloric acid or sodium hydroxide to adjust the pH between 4.5 and 7.5;
- (vii) optionally a drug(s) known to impair absorption of vitamin B12;
- and (viii) water for injection;
- wherein the solution is prepared under long wavelength light and optionally under nitrogen over-lay;
- wherein the viscosity of the solution is less than 100 cps.
6 more elements
A stable nasal spray composition of vitamin B12 comprising:
- (i) a therapeutic dose of vitamin B12;
- (ii) synergistic amounts of a polymer, carrageenan and potassium acetate;
- (iii) optionally a buffer to adjust pH of the formulation between 4.5 and 7.5;
- (iv) a preservative;
- (v) a humectant;
- (vi) purified water;
- (vii) optionally hydrochloric acid and/or sodium hydroxide to adjust the pH of the formulation between 4.5 and 7.5, and (viii) optionally a drug(s) known to impair absorption of vitamin B12;
- wherein the solution is prepared under long wavelength light and optionally under nitrogen over-lay wherein the viscosity of the nasal spray is less than 1000 cps.
5 more elements
Dependencies are inferred from the claim text.