Blend compositions for oral administration as a rapidly dissolving powder and/or suspension
Disclosed is a dry powder oral formulation that includes an active pharmaceutical ingredient (API), a lecithin powder, a galactomannan, one or more sweetening agents, one or more flavoring agents and an organic acid in a pharmaceutically acceptable preparation. Also disclosed are an excipient composition in absence of an API and methods of making and using the formulations and compositions. Also disclosed is a chewable, swallowable, and/or orally disintegrating tablet comprising an active pharmaceutical ingredient (API), a lecithin powder, a galactomannan, one or more sweetening agents, one or more flavoring agents and an organic acid in a pharmaceutically acceptable preparation.
1. A free flowing dry powder oral formulation suitable for administration in each of an aqueous solution, aqueous dispersion, tablet, and powder dosage form,
wherein the formulation comprises an active pharmaceutical ingredient (API) in an amount from about 3% w/w to about 15% w/w, a surfactant or emulsifier in an amount from 0.1% w/w to 1% w/w, a galactomannan in an amount from about 0.05% w/w to about 0.5% w/w, isomalt in an amount of from about 60% w/w to about 90% w/w, one or more flavoring agents in an amount from about 0.5% w/w to about 5% w/w and an organic acid in an amount from about 0.05% w/w to about 0.5% w/w, in a pharmaceutically acceptable preparation.
2. The formulation of claim 1 , wherein the API is ibuprofen in an amount of about 7.5% w/w.
3. The formulation of claim 2 , wherein the surfactant or emulsifier is present in an amount of about 0.5% w/w.
4. The formulation of claim 3 , wherein the galactomannan is present in an amount of about 0.25% w/w.
5. The formulation of claim 4 , wherein the organic acid comprises citric acid in an amount of about 0.125% w/w.
6. The formulation of claim 5 , wherein the one or more flavoring agents are present in an amount of about 3% w/w.
7. A formulation suitable for oral administration in a unit dosage form selected from powder, granulation, tablet, sphere, or capsule,
wherein the formulation comprises an active pharmaceutical ingredient (API) in an amount from about 3% w/w to about 15% w/w, a surfactant or emulsifier in an amount from 0.1% w/w to 1% w/w, a galactomannan in an amount from about 0.05% w/w to about 0.5% w/w, one or more sweetening agents in an amount of from about 1.0% w/w to about 90% w/w, one or more flavoring agents in an amount from about 0.5% w/w to about 5% w/w and an organic acid in an amount from about 0.05% w/w to about 0.5% w/w, in a pharmaceutically acceptable preparation.
8. The formulation of claim 7 , wherein the unit dose form is a tablet.
9. The formulation of claim 8 , wherein the tablet is a chewable tablet, a swallowable tablet, or a quick dissolving tablet.
10. The formulation of claim 7 , wherein the API is a non-steroidal anti-inflammatory drug (NSAID).
11. The formulation of claim 10 , wherein the NSAID is ibuprofen.
12. The formulation of claim 11 , wherein the wherein the unit dosage form comprises ibuprofen in an amount of about 50, about 75, about 100, about 200, about 400, about 600, or about 800 mg.
13. The formulation of claim 7 , wherein the one or more sweetening agents comprises isomalt.
14. The formulation of claim 7 , wherein the formulation comprises an active pharmaceutical ingredient (API) in an amount of about 7.5% w/w, a surfactant or emulsifier in an amount of about 0.5% w/w, a galactomannan in an amount of about 0.25% w/w, isomalt in an amount of from about 60% w/w to about 90% w/w, one or more flavoring agents in an amount of about 3.0% w/w, and citric acid in an amount of about 0.125% w/w.
15. The formulation of claim 7 , wherein the API is selected from the group consisting of aspirin, ibuprofen, naproxen, ketoprofen, sulindac, etodolac, fenoprofen, diclofenac, flurbiprofen, ketorolac, piroxicam, indomethacin, mefenamic, meloxicam, nabumetone, oxaprozin, ketoprofen, meclofenamate, tolmetin and salsalate.
16. A method of preparing a dry powder oral formulation of an API suitable for administration in each of an aqueous solution, aqueous dispersion, tablet, and powder dosage form, the method comprising, combining, in any order,
a) an API in an amount from about 3% w/w to about 15% w/w,
b) a surfactant or emulsifier in an amount from 0.1% w/w to 1% w/w
c) a galactomannan in an amount from about 0.05% w/w to about 0.5% w/w,
d) one or more sweetening agents in an amount from about 1.0% w/w to about 90% w/w,
e) one or more flavoring agents in an amount from about 0.5% w/w to about 5% w/w, and
f) an organic acid in an amount from about 0.05% w/w to about 0.5% w/w.
17. The method of claim 16 , wherein the API is selected from the group consisting of aspirin, ibuprofen, naproxen, ketoprofen, sulindac, etodolac, fenoprofen, diclofenac, flurbiprofen, ketorolac, piroxicam, indomethacin, mefenamic, meloxicam, nabumetone, oxaprozin, ketoprofen, meclofenamate, tolmetin and salsalate.
18. The method of claim 16 , wherein the API is ibuprofen.
19. The method of claim 16 , wherein the sweetening agent comprises isomalt.
20. The method of claim 19 , wherein the isomalt is present in an amount of from about 60% w/w to about 90% w/w.