Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1995-06-07
1997-05-20
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424464, 424473, 424484, A61K 920
Patent
active
056310234
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT U.S. Ser. No. 94/07618.
BACKGROUND OF THE INVENTION
(1) Field of the Invention
This invention concerns an improved method for manufacturing a therapeutic tablet that dissolves nearly instantaneously upon contact with water. This method improves upon traditional freeze-dry methods which include preparing an aqueous suspension containing a granular therapeutic agent, placing the aqueous suspension in molds, and freeze drying the aqueous suspension to produce a solid pharmaceutic tablet. The improved method of this invention incorporates a particular agent into the aqueous gelatin containing suspension in order to keep the granular therapeutic agent uniformly dispersed, but does so without degrading the speed of dissolution or the texture and "feel" of the tablet upon dissolution in the mouth.
(2) Description of the Art
Many pharmaceutical dosage forms are administered orally in the form of solid, shaped articles such as tablets, pills, and capsules that retain their shape under moderate pressure. Generally these dosage forms are designed to be swallowed whole, chewed, or retained sublingually or bucally in order to deliver the medication. Some patients, particularly pediatric and geriatric patients, have difficulty swallowing or chewing solid dosage forms. To assist these patients, therapeutic compounds are sometimes provided as a liquid or suspension. However, these dosage forms are often difficult to distribute and store due to problems with stability. Other patients may not have water available at the time that they should take medication, and patient compliance is accordingly reduced. Still other patients resist taking medication, and may try to hide a solid pill in order to spit it out later.
The prior art discloses methods for manufacturing therapeutic tablets that immediately dissolve on contact with saliva in the mouth. Many of these prior art manufacturing methods involve freeze drying aqueous drug formulations. U.S. Pat. No. 4,371,516, discloses shaped articles, carrying pharmaceuticals, which disintegrate rapidly in the mouth. The shaped articles comprise an open matrix of carrier material, interspersed with the medicament. The articles may be prepared by subliming solvent from a composition comprising the medicament and the carrier material in solution, the solution being in a solid state in the mold.
This unique dosage form provides a solid tablet means for delivering medicaments which disintegrates on the tongue of a patient within 10 seconds or less. This rapid tablet disintegration rate makes the dosage form suitable for patients who have difficulty swallowing or refuse to swallow conventional tablets containing such medicaments. Further, the dosage form is exceptionally convenient since it does not require the aid of water in order to be swallowed. As such, the rapidly disintegrating nature of the dosage form and the convenience associated with its use offer dramatic improvement in patient compliance and treatment of disease states.
U.S. Pat. No. 4,305,502, discloses packages containing shaped articles carrying chemicals, particularly dosage forms carrying pharmaceuticals. The shaped articles, which disintegrate rapidly in saliva, are contained in depressions in sheets of filmic material and are enclosed by a covering sheet adhering to the filmic material. The shaped articles may be formed in the depressions by a sublimation process.
U.S. Pat. No. 4,758,598, discloses the preparation of solid shaped articles, particularly pharmaceutical dosage forms, by freezing a composition comprising a predetermined amount of chemical (e.g., a pharmaceutically active compound) and a carrier material solution in a mold, and then subliming solvent from the frozen composition. The side wall or walls of the mold are angled to minimize sublimation times.
U.S. Pat. No. 4,754,597 discloses the preparation of solid shaped articles, particularly rapidly dissolving pharmaceutical dosage forms. The articles carry predetermined unit quantities of chemicals and are made by a novel p
REFERENCES:
patent: 4305502 (1981-12-01), Gregory et al.
patent: 4371516 (1983-02-01), Gregory et al.
patent: 4749790 (1988-06-01), Polomo-Coll et al.
patent: 4754597 (1988-07-01), Buxton et al.
patent: 4758589 (1988-07-01), Gregory
patent: 4894459 (1990-01-01), Bod et al.
patent: 4946684 (1990-08-01), Blank et al.
patent: 5021582 (1991-06-01), Ballester-Rodes
patent: 5064946 (1991-11-01), Shaver et al.
patent: 5075114 (1991-12-01), Roche
patent: 5178867 (1993-01-01), Guittard et al.
patent: 5206072 (1993-04-01), Roche et al.
patent: 5215756 (1993-06-01), Gole et al.
patent: 5275823 (1994-01-01), France et al.
Kearney Patrick
Wong Sang K.
Benston, Jr. William E.
Page Thurman K.
R.P. Scherer Corporation
LandOfFree
Method for making freeze dried drug dosage forms does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for making freeze dried drug dosage forms, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for making freeze dried drug dosage forms will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-1722231