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|Title:||Rapid immediate release oral dosage form|
|Abstract:||A pharmaceutical composition comprising lactitol and one or more amphetamine salts in a rapid release formulation.|
|Inventor(s):||Flanner; Henry H. (Montgomery Village, MD), Chang; Rong-Kun (Rockville, MD), Pinkett; Jill E. (Baltimore, MD), Wassink; Sandra E. (Frederick, MD), White; Lisa R. (Damascus, MD)|
|Assignee:||Shire Laboratories, Inc. (Rockville, MD)|
1. A pharmaceutical composition comprising a tablet, said tablet including (i) a pharmaceutical active selected from the group consisting of amphetamine base, salts, chemical
and chiral derivatives thereof, and mixtures thereof; (ii) lactitol; and (iii) micro crystalline cellulose.
2. The composition of claim 1 wherein said pharmaceutical active comprises a mixture of amphetamine salts.
3. The composition of claim 2 wherein said amphetamine salts are selected from the group consisting of d-amphetamine sulfate, d,l-amphetamine aspartate, d-amphetamine saccharate, and d,l-amphetamine sulfate.
4. The composition of claim 3 wherein said d-amphetamine sulfate, d,l-amphetamine aspartate, d-amphetamine saccharate, and d,l-amphetamine sulfate are present in said composition in a ratio of 1:1:1:1.
5. The composition of claim 1 wherein said lactitol and said microcrystalline cellulose are present in said composition at a ratio of lactitol to microcrystalline cellulose of 2-5:0.25-1.75.
6. The composition of claim 5 wherein said lactitol and said microcrystalline cellulose are present in said composition at a ratio of lactitol to microcrystalline cellulose of 3-4: 0.5-1.5.
7. The composition of claim 1 and further comprising an antiadherant or glidant.
8. The composition of claim 7 wherein said antiadherant or glidant is selected from the group consisting of talc, corn starch, silicon dioxide, sodium lauryl sulfate, and metallic stearates.
9. The composition of claim 1 and further comprising a lubricant.
10. The composition of claim 9 wherein said lubricant is selected from the group consisting of magnesium stearate, calcium stearate, sodium stearate, stearic acid, sodium stearyl fumarate, sterotex, talc, colloidal silicon dioxide, and waxes.
11. The composition of claim 1 and further comprising a binding agent.
12. The composition of claim 11 wherein said binding agent is selected from the group consisting of polyvinyl pyrrolidone, starch, methyl cellulose, hydroxypropyl methylcellulose, and carboxymethyl cellulose.
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