Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1998-08-18
2001-08-07
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S439000, C424S489000, C424S490000, C424S493000, C424S494000, C424S497000
Reexamination Certificate
active
06270790
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: 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: 5609883 (1997-03-01), Valentine et al.
patent: 5686107 (1997-11-01), Ratnaraj et al.
patent: 5876759 (1999-03-01), Gowan, Jr.
patent: 98/46215 (1998-10-01), None
Muresan et al., Stability Study if Pyroxicam in the Presence of Auxiliary Substances of Compression, Farmacia 41, No. 1-2, pp. 51-56, 1993.*
Danckwerts et al., The Effect of Processing Variables in the Compression Properties of Controlled Release Core-In-Cup Compressed Tablets from a New Adjustable Punch, International Journal of Pharmaceutics, 123 pp. 85-94, 1995.*
Westerhuis et al., Optimisation of the Composition and Production of Mannitoll/Microcrystalline Cellulose Tablets, International Journal of Pharmaceutics, 143 pp. 151-162, 1996.*
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.*
Ambros et al., The Characterization of the Mechanical Strength of Chewable Tablets, Pharm. Develop. Technol. 3, No. 4 pp. 509-15, 1998.*
Morris et al., Characterization and Performance of a New Direct Compression Excipient for Chewable Tablets: Xylitab, Drug Dev. Ind. Pharm., 22, No. 9-10 pp. 925-32, 1996.*
Pitt et al., J. Pharm. Pharmacol., vol. 41, p. 289-292 (1989).
Gold et al., Journal of Pharmaceutical Sciences, vol. 69, No. 4, p. 384-386 (1980).
Gold et al., Pharmaceutical Technology, Dec. 1983, p. 31-38 and 71 (1983).
Sugimori et al. Powder Technology, vol. 58, p. 259-264 (1989).
Chakrabarti et al. The Indian Journal of Pharmacy, vol. 37, No. 3, p. 62-65 (1975).
J. Pharm. Pharmac., vol. 24, p. 503-504 (1992).
Aulton, M.E., Pharm. Helv. vol. 56, No. 12, p. 332-6 (1981).
Hwang et al. Drug Development and Industrial Pharmacy, vol. 19, No. 5, p. 507-19 (1973).
Horikoshi, et al. Chem. Pharm. Bull., vol. 21, No. 10, p. 2136-40 (1973).
Pitt et al., J. Pharma. Pharmacol., vol. 42, p. 219-225 (1990).
Chowhan et al. Journal of Pharmaceutical Sciences, vol. 81, No. 3, p. 290-94 (1992).
Leonard et al., Drug Development and Industrial Pharmacy, vol. 15, No. 3, p. 434-359 (1989).
Kigasawa et al. Yakugaku Zasshi, vol. 95, No. 7, p. 769-773 (1975).
Damon James R.
Mossop James R.
Palmer Michael D.
Robinson Ronni L.
MxNeil-PPC, Inc.
Page Thurman K.
Plantz Bernard F.
Seidleck Brian K.
LandOfFree
Soft, convex shaped chewable tablets having reduced friability 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, convex shaped chewable tablets having reduced friability, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Soft, convex shaped chewable tablets having reduced friability will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2486805