Film coated tablet for improved upper gastrointestinal tract safety

Inactive Publication Date: 2007-03-29
THE PROCTER & GAMBLE COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006] The present invention is directed to a pharmaceutical formulation in an oral generally oval shaped, including but not limited to oval, modified oval and caplet shaped form. The dosage form is film coated and comprised of a safe and effective amount of an active ingredient and pharmaceu

Problems solved by technology

It is hypothesized that said irritation results from the active ingredient coming in direct contact with those epithelial and mucosal tissues, resulting in the topical irritation thereof.
Particularly problematic drugs are those which when dissolved have a

Method used

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  • Film coated tablet for improved upper gastrointestinal tract safety
  • Film coated tablet for improved upper gastrointestinal tract safety
  • Film coated tablet for improved upper gastrointestinal tract safety

Examples

Experimental program
Comparison scheme
Effect test

example i

Modified Oval, Film-Coated Risedronate Tablet

[0063] The film-coating is applied to 110 kg of risedronate core tablets each weighing 240 mg.

Componentkg / batchmg / tabletRisedronate sodium tablets 30 mg110240Dri-Klear2.5985.67Chroma-Tone White0.7011.53Purified Water30.2kg65.9

[0064] Dri-Klear is a mixture of HPMC, HPC, polyethylene glycol, and silicon dioxide manufactured by Crompton and Knowles, Marwah, N.J., Chroma-Tone White is a mixture of HPC and titanium dioxide manufactured by Crompton and Knowles, Marwah, N.J.

[0065] The coating suspension is prepared as follows: [0066] 1. Add the Dri-Klear to hot purified water, 60-80° C., with agitation. [0067] 2. Cool the Dri-Klear solution to 40° C. or below, with continual mixing until all the Dri-Klear is dissolved. [0068] 3. Add the Chroma-Tone White to purified water with mixing. Disperse with the use of a high shear mixer for 10-25 minutes. [0069] 4. Add the pigment suspension (step 3) to the polymer solution (step 2) and mix. Continue...

example ii

Caplet Shaped, Film-Coated Alendronate Tablet

[0073] The film-coating is applied to 100 kg of alendronate core tablets each weighing 200 mg.

Componentkg / batchmg / tabletAlendronate sodium tablets 10 mg100200.0Opadry5.010.0Red iron oxide0.10.2Purified Water50kg100

[0074] Opadry is a commercial film-coating mixture manufactured by Colorcon, West Point, Pa. The coating suspension is prepared as follows: [0075] 1. Add the Opadry to room temperature purified water with agitation. [0076] 2. Mix until all the Opadry is dissolved. [0077] 3. Add the red iron oxide to purified water with mixing. Disperse with the use of a high shear mixer for 5 minutes. [0078] 4. Add the red iron oxide suspension (step 3) to the polymer solution (step 2) and mix.

[0079] Continue mixing until ready for use. [0080] 5. Load the core tablets into a 48 inch side vented coating pan. [0081] 6. Preheat the tablets until the exhaust temperature reaches approximately 40° C. and begin spraying. Apply the coating suspensio...

example iii

Oval Risedronate Tablets

[0083] The film-coated risedronate tablets are made by preparing granules containing the active, coating the granules, compressing into a tablet and then film-coating the tablets.

[0084] A. Preparation of the risedronate sodium granules, 212.5 kg

Componentkg / batchmg / g (Dry basis)Risedronate sodium2.511.7Lactose, anhydrous100471Microcrystalline cellulose100471Polyvinylpyrrolidone1047.1Purified Water75kg—

The granulation is prepared as follows: [0085] 1. Dissolve the polyvinylpyrrolidone in the purified water. [0086] 2. Mix the risedronate sodium, lactose and microcrystalline cellulose in a high shear mixer for 3 minutes. [0087] 3. Granulate the mixture with the polyvinylpyrrolidone solution with mixing over a 5 minute interval. [0088] 4. Dry the wetted mass in a fluid bed dryer at an inlet temperature of 60° C. [0089] 5. Mill the dried material using a hammer mill to achieve the desired granule size.

[0090] B. Coating of the granules and preparation of rised...

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Abstract

A novel oral dosage to be delivered to the stomach comprising a safe and effective amount of an active ingredient selected from the group consisting of emepronium bromidebromide, doxycycline, and other tetracyclines/antibiotics, iron preparations, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine (AZT), bisphosphonates and mixtures thereof and pharmaceutically-acceptable excipients, wherein said oral dosage form is a generally oval form and film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus.

Description

CROSS REFERENCE [0001] This application is a continuation of prior U.S. application Ser. No. 10 / 401,352 filed on Mar. 28, 2003 and which claims priority to application Ser. No. 09 / 694,799 filed Oct. 23, 2000, allowed on Jan. 2, 2003, now U.S. Pat. No. 6,569,460, issued May 27, 2003, which is a Continuation of U.S. application Ser. No. 09 / 095,322 filed Jun. 10, 1998, now U.S. Pat. No. 6,165,513, issued Dec. 26, 2000 which claims the benefit of U.S. Provisional Application Ser. No. 60 / 049,306 filed Jun. 11, 1997.TECHNICAL FIELD [0002] The present invention relates to novel oral dosage forms that protect the epithelial and mucosal tissues of the mouth and the buccal cavity, the pharynx, the larynx, and the esophagus from erosion, ulceration, or other like irritation suffered by direct contact of these tissues with the active ingredient. The tablet is a modified oval shape and is film coated. This invention further relates to a method of treating or preventing diseases characterized by ...

Claims

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Application Information

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IPC IPC(8): A61K31/65A61K9/26A61K9/24A61K9/30A61K9/28A61K9/34A61K9/36A61K31/138A61K31/375A61K31/401A61K31/49A61K31/522A61K31/66A61K31/675A61K45/00A61K47/32A61K47/38A61K47/42A61P1/04
CPCA61K9/2081Y10S514/964A61K31/138A61K31/375A61K31/401A61K31/49A61K31/522A61K31/65A61K31/663A61K31/675A61K31/7072Y10S514/821Y10S514/96Y10S514/962Y10S514/963Y10S514/961A61K9/2866A61P1/00A61P1/04A61P19/08A61K9/28
Inventor DANSEREAU, RICHARD JOHNBEKKER, PETRUS JAKOBUS
Owner THE PROCTER & GAMBLE COMPANY
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