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Claims for Patent: 5,599,557

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Claims for Patent: 5,599,557

Title: Stable hydrated cephalosporin dry powder for oral suspension formulation
Abstract:A dry hydrated cephalosporin, e.g. ceftibuten having about 7 to 14% by weight of water, powder formulation, pharmaceutical compositions in the form of an oral suspension dosage form and a method of making the dry powder formulations are disclosed.
Inventor(s): Johnson; Donald A. (Miami Lakes, FL), Wearley; Lorraine (Westfield, NJ), Galeos; Rebecca (Bloomfield, NJ), Sequeira; Joel A. (New York, NY)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:08/325,400
Patent Claims: 1. A method of preparing a dry hydrated cephalosporin powder formulation which is resistant to air oxidation and dehydration and is suitable for suspension in water to form a orally administerable product which comprises admixing at ambient temperature and humidity conditions, a hydrated cephalosporin or a pharmaceutically acceptable salt thereof in the form of a dry solid powder with substantially dry pharmaceutically acceptable excipients selected from the group consisting of surfactants, suspending agents thickening agents, opacificers, preservatives, and sweeteners to form a dry admixture transferring the so-formed dry admixture to a sealable storage container opaque to incident visible radiation under an atmosphere containing no more than about 5 volume percent oxygen.

2. The process of claim 1 wherein the hydrated cephalosporin is ceftibuten trihydrate containing about 7 to about 14% by weight of water.

3. A dry hydrated ceftibuten powder formulation suitable for constitution with a pharmaceutically acceptable carrier to form a pharmaceutical composition in a stable suspension oral dosage form comprising:

(1) an antibacterially effective amount of hydrated ceftibuten containing about 7 to 14 weight percent water;

(2) an effective amount of a nonionic surfactant;

(3) an effective amount of an antifoaming agent;

(4) an amount of thickening agents effective for thickening the suspension selected from the group consisting of silicon dioxide and at least one of aluminum magnesium silicate, a mixture of microcrystalline cellulose and carboxymethyl cellulose in the ratio of 6:1 to 10:1 (w/w) and xanthan gum;

(5) an effective amount of an opacifier; and

(6) an amount of a sweetener or sweetener composition.

4. A stable, dry hydrated ceftibuten powder formulation suitable for use as an oral suspension dosage form in water, which comprises:

5. The stable, dry hydrated ceftibuten powder formulation of claim 4 wherein the ingredients are present in the following amounts:

6. A pharmaceutical composition suitable for oral administration comprising an antibacterially effective amount of the formulation of claim 4 and an amount of sterilized water sufficient to form a suspension of the formulation in water which suspension is stable to settling for an unexpectedly extended period of time.

7. The formulation of claim 4 wherein the sweetener formulation is sucrose.

8. The dry hydrated ceftibuten powder formulation of claim 4 wherein the ceftibuten dihydrate is used.

9. The dry hydrated ceftibuten powder formulation of claim 3 wherein the ceftibuten dihydrate is used.

10. The dry hydrated ceftibuten powder formulation of claim 4 wherein the formulation is maintained in the presence of an atmosphere containing less than about 5% by volume of oxygen.

11. The pharmaceutical composition of claim 6 wherein ceftibuten dihydrate is used.

12. A method of treating susceptible bacterial infections in a host susceptible to or afflicted with said infections which comprises administering an antibacterially effective amount of the formulation of claim 4 together with an amount of sterilized water sufficient to form a suspension.

13. The method of claim 12 wherein ceftibuten dihydrate is used.

14. A pharmaceutical composition suitable for oral administration comprising an antibacterially effective amount of the formulation of claim 3 and an amount of sterilized water sufficient to form a suspension of the formulation in water which suspension is stable to settling for an unexpectedly extended period of time.
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