Tablet comprising crospovidone
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10159647-B2
Publication Date
2018-12-25
Expiration Date
Abstract
The present invention relates to a dispersible tablet comprising crospovidone, notably a tablet comprising crospovidone and a β-lactam antibiotic such as amoxicillin, to a method for preparing said tablet and to the use of said tablet.
Core Innovation
The invention relates to a noncoated dispersible tablet comprising a β-lactam antibiotic and a disintegrant in a defined amount by weight. The disintegrant comprises crospovidone present within a specific weight range, and the tablet further contains one or more pharmaceutically acceptable excipients in the form of a mixture.
The invention addresses the problem of achieving very rapid water disintegration of a noncoated dispersible tablet while using a low amount of crospovidone disintegrant. The tablet is characterized by disintegration performance defined by a specified test condition.
The tablet disintegrates within a specified time window after being placed in water under the WHO tablet disintegration test conditions, including water at 15–25°C and use of the specified WHO document section. The framework further allows defined excipients and optional components such as microcrystalline cellulose, a lubricant, and one or more of a flavor and sweetener in the form of a mixture.
Additional optional features described include specific β-lactam identities such as amoxicillin trihydrate, optional additives including β-lactamase inhibitors and artificial flavor, and constraints on certain residual compounds such as dichloromethane, isopropanol, pivalic acid, and triethyl amine.
Claims Coverage
The independent claims are directed to noncoated dispersible tablets with a crospovidone-containing disintegrant at defined weight percentages and defined disintegration performance under specified WHO test conditions. Across the independent claims, four main inventive features are consistently required: the tablet being noncoated and dispersible, the specific crospovidone content, the mixture form of listed components, and the disintegration-time requirement in water at 15–25°C per the specified WHO document section.
Noncoated dispersible tablet with β-lactam antibiotic and crospovidone disintegrant
A noncoated dispersible tablet comprising a β-lactam antibiotic and from 0.65–1.6% by weight of the tablet of a disintegrant, wherein said disintegrant comprises crospovidone present in an amount of 0.80–0.15% by weight of the tablet, and one or more pharmaceutically acceptable excipients.
Mixture form of β-lactam antibiotic, disintegrant, and pharmaceutically acceptable excipients
The β-lactam antibiotic, the disintegrant and the pharmaceutically acceptable excipients in the tablet are in the form of a mixture.
Defined disintegration in water under WHO tablet disintegration test conditions
The tablet disintegrates within from 30 to 120 seconds after being placed in water in accordance with section 5.3 of the specified WHO document using water at a temperature of 15–25°C.
Tablet formulation including microcrystalline cellulose, lubricant, and flavor/sweetener in mixture form
A noncoated dispersible tablet comprising a β-lactam antibiotic and from 0.65–1.6% by weight of the tablet of a disintegrant which comprises crospovidone, wherein crospovidone is present in an amount of 0.80–0.15% by weight of the tablet, microcrystalline cellulose, a lubricant and one or more of a flavor and sweetener, with the β-lactam antibiotic, disintegrant, microcrystalline cellulose, lubricant and flavor and/or sweetener in the form of a mixture.
Overall, the claim coverage centers on a noncoated dispersible tablet formulation that includes a β-lactam antibiotic and a crospovidone-containing disintegrant in specified weight percentages, with key components present as a mixture. The tablet is further constrained by rapid disintegration within 30 to 120 seconds in water at 15–25°C under the specified WHO test section, and (in the second independent claim) includes microcrystalline cellulose, a lubricant, and flavor and/or sweetener in mixture form.
Stated Advantages
Very rapid water disintegration performance under the WHO tablet disintegration test conditions.
Allows very low levels of crospovidone disintegrant while targeting acceptable disintegration performance versus prior art.
Documented Applications
No documented applications found
Interested in licensing this patent?