Manage your formulary budget
Find generic entry opportunities
Deep knowledge on
small-molecule drugs and
the 110,000 global patents
Anticipate generic drug launch
Drug patents …
… from Kazakhstan to Kalamazoo
Proactively manage your pharmacy inventory
Flat-rate pricing for predictable budgeting
Short-term plans for project- or client-based billing
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|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)|
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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.