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US4304773A Expired / Lapsed US ⏱️ 0.0 years remaining

Novel bendroflumethiazide formulations and method

Assignee: ER Squibb and Sons LLC
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Filing: 1980-06-26
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Granted: 1981-12-08
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Expires: 2000-06-26
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Abstract

Abstract New bendroflumethiazide formulations in solid form are provided which are characterized by excellent disintegration and dissolution capabilities even after long periods of storage. The new bendroflumethiazide formulations, for example, in the form of tablets, contain in addition to bendroflumethiazide, a combination of microcrystalline cellulose which serves as a diluent and aids in disintegration of the tablets, lactose which serves as a diluent, optionally starch (in the gelatinized form) which serves as a disintegrant, and one or more auxilliary disintegrants, such as sodium carboxymethyl starch, a tablet lubricant, such as magnesium stearate, and a colorant, if desired. A method for preparing the above formulations is also provided.

Inventors

  • 👤 Thomas M. Wong
  • 👤 Mahendra R. Patel

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-25 04:33
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/33; A61K31/395; A61K31/54; A61K9/00; A61K9/20; A61K9/2004

Claims Analysis

Total Claims: 11
Claim 1
Independent Claim 133 words
A solid bendroflumethiazide formulation, substantially free of water, having excellent disintegration and dissolution properties even upon aging, consisting essentially of bendroflumethiazide, microcrystalline cellulose, and starch as a disintegrant in an amount within the range of from about 15 to about 30% by weight of the formulation and auxiliary disintegrant selected from the group consisting of sodium carboxymethyl starch, modified cellulose gum or polyvinyl pyrrolidone, the microcrystalline cellulose being present in a weight ratio to the bendroflumethiazide of within the range of from about 5:1 to about 24:1, the starch being present in a weight ratio to the bendroflumethiazide of within the range of from about 5:1 to about 9:1 and the auxiliary disintegrant being present in a weight ratio to the bendroflumethiazide of within the range of from about 0:1 to about 2:1.
Claim 2
Dependent Claim 133 words
A solid bendroflumethiazide formulation, substantially free of water, having excellent disintegration and dissolution properties even upon aging, consisting essentially of bendroflumethiazide, microcrystalline cellulose, and starch as a disintegrant in an amount within the range of from about 15 to about 30% by weight of the formulation and auxiliary disintegrant selected from the group consisting of sodium carboxymethyl starch, modified cellulose gum or polyvinyl pyrrolidone, the microcrystalline cellulose being present in a weight ratio to the bendroflumethiazide of within the range of from about 5:1 to about 24:1, the starch being present in a weight ratio to the bendroflumethiazide of within the range of from about 5:1 to about 9:1 and the auxiliary disintegrant being present in a weight ratio to the bendroflumethiazide of within the range of from about 0:1 to about 2:1.
Claim 3
Dependent Claim 51 words
The formulation as defined in claim 1 further including from about 10 to about 80% by weight of a lactose diluent or starch diluent and from about 0.1 to about 0.5% by weight of a lubricant selected from the group consisting of magnesium stearate, cornstarch, talc, stearic acid and mixtures thereof.
Claim 4
Dependent Claim 43 words
The formulation as defined in claim 1 wherein the microcrystalline cellulose is present in an amount of from about 10 to about 60% by weight, and the auxiliary disintegrant is present in an amount of from about 0 to about 5% by weight.
Claim 5
Dependent Claim 55 words
The formulation as defined in claim 1 wherein the microcrystalline cellulose is present in a weight ratio to the bendroflumethiazide of within the range of from about 6:1 to about 11:1, and the auxiliary disintegrant is present in a weight ratio to the bendroflumethiazide of within the range of from about 0.5:1 to about 1:1.
Claim 6
Dependent Claim 14 words
The formulation as defined in claim 1 wherein the starch is gelatinized corn starch.
Claim 7
Dependent Claim 19 words
The formulation as defined in claim 1 wherein the auxiliary disintegrant is sodium carboxymethyl starch or modified cellulose gum.
Claim 8
Dependent Claim 15 words
The formulation as defined in claim 1 wherein the auxiliary disintegrant is sodium carboxymethyl starch.
Claim 9
Dependent Claim 16 words
The formulation as defined in claim 1 comprising microcrystalline cellulose, gelatinized starch, and sodium carboxymethyl starch.
Claim 10
Dependent Claim 12 words
The formulation as defined in claim 2 wherein the diluent is lactose.
Claim 11
Dependent Claim 13 words
The formulation as defined in claim 2 wherein the lubricant is magnesium stearate.

References Cited (Backward Citations)

US3265573A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1984-12-07 1985-06-08 1985-12-08 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1988-12-07 1989-06-08 1989-12-08 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1992-12-07 1993-06-08 1993-12-08 $7700.00 Window Closed / Lapsed

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