Palatable suspending vehicle for pharmaceutical ingredients
The invention relates to a liquid vehicle that can be used to create suspensions and/or solutions of liquid or powdered medications. The vehicle is thixotropic and has improved stability and rheologic characteristics. Vehicles of the invention include an aqueous medium and a suspending agent comprising a polysaccharide having at least 50% glucose repeating saccharide units and at least 90% alpha linkages. The polysaccharide can be a starch, modified starch, or glycogen. The aqueous medium and individual components of the vehicle provide a palatable and easily ingested drug preparation. The invention also provides a vehicle containing an aqueous medium, suspending agent comprising a polysaccharide having at least 50% glucose repeating saccharide units and at least 90% alpha linkages, buffer, and artificial sweetener, the combined suspending vehicle having a pH of about 3 to about 10 and an osmolality of 300 mOmsol or less.
1. A method of preparing a drug in an oral dosage form for treatment of a patient, comprising admixing the drug with a vehicle to form an oral dosage form wherein the drug is suspended in the vehicle, the vehicle comprising:
a) an aqueous medium;
b) about 1% to about 15% by weight of a suspending agent, wherein the suspending agent is a starch or glycogen;
c) an artificial sweetener;
d) a pH of about 3 to about 10;
e) a buffer comprising an organic acid, inorganic acid, salts thereof, or mixtures thereof; and
f) osmolality of about 300 mOsmol or less;
wherein the vehicle is thixotropic and a pseudoplastic power law fluid comprising a consistency index of at least 400 at a shear rate of about 1 sec −1 .
2. The method of claim 1 , wherein the starch is a modified starch.
3. The method of claim 1 , wherein the starch comprises an amylose to amylopectin ratio of about 20%:80% to about 60%:40% by weight.
4. The method of claim 1 , wherein the vehicle comprises a yield value greater than 0.
5. The method claim 4 , wherein the vehicle comprises a yield value of about 0.01 dynes/cm 2 to about 60 dynes/cm 2 .
6. The method of claim 4 , wherein the vehicle comprises a flow index of less than about 0.8 at a shear rate of less than about 1 sec −1 .
7. The method of claim 1 , wherein the vehicle comprises a pH of about 3 to about 5.
8. The method of claim 1 , wherein the vehicle further comprises:
a) a preservative;
b) an antimicrobial agent;
c) an anti-oxidant;
d) a flavoring agent;
e) a flavor enhancer;
f) a colorant;
g) a texture modifier;
h) a surfactant; or
i) a defoaming agent.
9. The method of claim 1 , wherein the organic acid comprises malic acid, citric acid, ascorbic acid, tartaric acid, adipic acid, lactic acid, furmaric acid, maleic acid, acetic acid, phosphoric acid, a salt thereof, or mixtures thereof.
10. The method of claim 1 , wherein the artificial sweetener comprises sucralose, aspartame, saccharin, stevia, acesulfame-K, or mixtures thereof.
11. The method of claim 1 , wherein the vehicle comprises about 1% or less artificial sweetener by weight.
12. The method of claim 1 , wherein the vehicle comprises osmolality of about 50 mOsmol or less.
13. The method of claim 1 , wherein the vehicle comprises osmolality of about 30 mOsmol to about 40 mOsmol.
14. The method of claim 1 , wherein high shear mixing is not required to uniformly distribute the drug within the vehicle.
15. The method of claim 1 , wherein the vehicle comprises a consistency index of about 400 to about 30,000 at a shear rate of about 1 sec −1 .
16. The method of claim 1 , wherein the starch comprises hydrated starch granules.
17. The method of claim 1 , wherein vehicle comprises at least about 70% by weight of the aqueous medium.
18. The method of claim 1 , wherein the drug is a solid dosage form that is ground to a powder and then admixed with the vehicle.
19. A method of administering a drug to a patient, comprising preparing a drug in an oral dosage form according to claim 1 and orally administering the oral dosage form to the patient.