Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2001-06-13
2002-10-29
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S441000, C424S465000, C424S439000
Reexamination Certificate
active
06471991
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to soft, convex-shaped compressed chewable tablets and a process for preparing such tablets.
BACKGROUND OF THE INVENTION
Chewable tablets are widely used in the pharmaceutical industry for patients, such as children, who have who have difficulty swallowing conventional tablets or capsules. Children's TYLENOL® Chewable Tables are an example of a pediatric chewable acetaminophen tablet sold in the United States. These tables are packaged in bottles and have a flat face, beveled edge shape. Samples of these tablets obtained from retail locations had hardnesses (average of ten tablets) ranging from 5.3-13.1 kp or normalized hardnesses of 12.3-30.5 kp/cm
2.
Many comercially avaialable pediatric chewable tablets contain active ingredients which are coated with polymers to mask their unpleasant taste. However, the forces used to compress these tablets can fracture the polymer coatings, which reduces the effectiveness of the tastemasking system.
Rapidly disintegrating dosage forms, such as those described in U.S. Pat. No. 5,464,632, issued Nov. 7, 1995, are also available for patients, particularly aged and pediatric patients, having difficluties swallowing tablets and caplets. However, rapidly disintegrating dosage forms currently available are highly friable, and require the use of special handling and costly packaging, e.g., specially designed blister packs, to prevent breakage or chipping of the tablets. These limitations significantly increase the product cost.
Tablet shape also affects tablet friability. T. Chakrabarti et al. in
The Indian Journal of Pharmacy,
Vol. 38, No. 3, pp. 62-65 (1975) disclose that lower friability was observed in beveled flat tablets followed by standard convex and plain flat tablets. Similarily, K. Sugimori et al. in
Powder Technology
, Vol. 58, pp. 259-264 (1989) report that capping occurs more often in convex-shaped tablets than flat faced tablets.
A need, therefore, exists for compressed, chewable tablets having improved taste, but which exhibit low friability so that they may be processed with standard bulk handling equipment and packaged in bottles.
SUMMARY OF THE INVENTION
The present invention provides a compressed, chewable tablet containing at least one active ingredient, a water-disintegratable, compressible carbohydrate and a binder. These components are dry blended and compressed into a convex-shaped tablet having a hardness of about 2 to about 11 kp/cm
2
. The tablet has a friability of less than 1%.
In a preferred embodiment of the present invention, the compressed, chewable tablet is prepared by dry blending the active ingredient, water-disintegratable, compressible carbohydrate and binder, and then compressing into a convex-shaped tablet having a hardness of about 2 to about 11 kp/cm
2
. If the active ingredient has an objectionable taste, it is coated with a taste masking composition.
Compressing at reduced force reduces fracture of the coating used for masking the unpleasant taste of the active ingredient. These convex-shaped, chewable tablets are softer that conventional chewable tablets, which results in improvements in product taste, mouthfeel, and ease of chewing.
The convex tablet geometry significantly reduces tablet friability at a given compression force. This reduction in tablet friability allows for the use of lower compression forces and lower tablet hardness, while maintaining the ability to process the tablets with conventional bulk handling equipment and package them in conventional bottles.
REFERENCES:
patent: 3431339 (1969-03-01), Gyarmathy et al.
patent: 3619292 (1971-11-01), Brouillard et al.
patent: 4760094 (1988-07-01), Blank et al.
patent: 4851226 (1989-07-01), Julian et al.
patent: 5075114 (1991-12-01), Roche
patent: 5275823 (1994-01-01), France et al.
patent: 5460825 (1995-10-01), Roche et al.
patent: 5464632 (1995-11-01), Cousin et al.
patent: 5489436 (1996-02-01), Hoy et al.
patent: 5536526 (1996-07-01), Virtanen et al.
patent: 5609883 (1997-03-01), Valentine et al.
patent: 5686107 (1997-11-01), Ratnaraj et al.
patent: 5876759 (1999-03-01), Gowan, Jr.
patent: 6221392 (2001-04-01), Khankari et al.
patent: 0 180 364 (1986-05-01), None
patent: 0 196 546 (1986-10-01), None
patent: 0 636 364 (1995-02-01), None
patent: 0 717 986 (1996-06-01), None
patent: WO 91/00096 (1991-01-01), None
patent: WO 95/00121 (1995-01-01), None
patent: 98/46215 (1998-10-01), None
Muntean et al., Formulation and Preparation of Some Chewable Tablets for Local Treatment of Bucco-Pharyngeal Infections, Farmacia 41, No. 1-2, pp. 51-56 (1993).*
Muresan et al., Stability Study of Pyroxicam in the Presence of Auxiliary Compression Substances, Farmacia 41, No. 3-4, pp. 51-55 (1993).*
Muresan et al., Stability Study of Pyroxicam in the Presence of Auxiliary Compression Substances, Farmacia 41, No. 3-4, pp. 51-55 (1993).*
Chowhan, et al.,Journal of Pharmaceutical Sciences, vol. 81, No. 3, pp. 290-294 (1992).
Leonard, et al.,Drug Development and Industrial Pharmacy, vol. 15, No. 3, pp. 343-359 (1989).
Kigasawa, et al.,Yakugaku Zasshi, vol. 95, No. 7, pp. 769-773 (1975).
Pitt, et al.,J. Pharm. Pharmacol., vol. 41, pp. 289-292 (1989).
Gold, et al.,Journal of Pharmaceutical Sciences, vol. 69, No. 4, pp. 384-386 (1980).
Gold, et al.,Pharmaceutical Technology, Dec. 1983, pp. 31-38 and 71 (1983).
Sugimori, et al.,Power Technology, vol. 58, pp. 259-264, (1989).
Chakrabarti, et al.,The Indian Journal of Pharmacy, vol. 37, No. 3, pp. 62-65 (1975).
J. Pharm. Pharmac., vol. 24, pp. 503-504 (1992).
Aulton, M.E.,,Pharm. Acta. Helv., vol. 56, No. 12, pp. 332-336 (1981).
Hwang, et al.,Drug Development and Industrial Pharmacy, vol. 19, No. 5, pp. 507-519 (1993).
Horikoshi, et al.,Chem. Pharm. Bull., vol. 21, No. 10, pp. 2136-2140 (1973).
Pitt, et al.,J. Pharm. Pharmacol., vol. 42, pp. 219-225 (1990).
Muresan, et al.,Stability of Piroxicam In the Presence of Auxiliary Compression Substances, Farmacia(1993), 41(3-4), 51-55.
Lieberman, et al.,Pharmaceutical Dosage Forms, Marcel Dekker, Inc., 2nded., vol. 1 (1989) pp. 205-214; vol. 2 (1990) pp. 213-217, 327 & 328; vol. 3 (1990) pp. 138-150.
Danckwerts, et al.,The Effect of Processing Variables on the Compression Properties of Controlled Release Core-In-Cup Compressed Tablets From a New Adjustable Punch, Intenational Journal of Pharmaceutics, 123, pp. 85-94 (1995).
Westerhuis, et al.,Optimisation of the Composition and Production of Mannitol/Microcrystalline Cellulose Tablets, International Journal of Pharmaceutics, 143, pp. 151-162, (1996).
Abstract #94-11609 for Muntean, et al.,Formulation and Preparation of Some Chewable Tablets for Local Treatment of Bucco-Pharyngeal Infections, Farmacia 41, No. 1-2, pp. 51-56. (1993).
Abstract #99-03229 for Ambros, et al.,The Characterization of the Mechanical Strength of Chewable Tablets, Pharm. Develop. Technol. 3, No. 4, pp. 509-515. (1998).
Morris, et al.,Characterization and Performance of a New Direct Compression Excipient for Chewable Tablets: Xylitab®, drug. Dev. Ind. Parm., 22, No. 9-10, pp. 925-932. (1996).
Tablet Friability Apparatus <1216>, USP 23, 1995.
McNeil-PPC, Inc., PCT/EP 99306455, Search Report.
Damon James R.
Mossop James R.
Palmer Michael D.
Robinson Ronni L.
Howard S.
Mc-Neil-PPC, Inc.
Page Thurman K.
Plantz Bernard F.
LandOfFree
Soft chewable tablets having convexed shaped face surfaces does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Soft chewable tablets having convexed shaped face surfaces, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Soft chewable tablets having convexed shaped face surfaces will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2986775