Oral dosage form containing a fast release exterior coating
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Publication Number
US-11433037-B2
Publication Date
2022-09-06
Expiration Date
Abstract
Aspects of the present invention are directed to an oral dosage form comprising a core containing one more active ingredients and a fast-release exterior coating. The fast release exterior coating includes a water soluble polymer; a saccharide or sugar alcohol, or a combination thereof, and a flavoring. The flavoring may be a warming sensate that is released in the oral cavity of the user after inserting the dosage form in his or her mouth.
Core Innovation
A coated oral dosage form provides a sensorial experience in the oral cavity of the user. The oral dosage form comprises a core and a layered coating system including a fast-release exterior coating and an intermediate coating. The core comprises acetaminophen, dextromethorphan, and phenylephrine in defined amounts.
The fast-release exterior coating comprises hydroxypropylmethylcellulose, polyethylene glycol, maltodextrin, and warming sensate. This fast-release exterior coating is formulated to provide the sensorial experience in the oral cavity. An intermediate coating comprising hydroxypropylmethylcellulose and polyethylene glycol is included as a separate coating layer.
The coated oral dosage form further defines quantitative ranges and configurations for coating components and coating layers. The layered structure defines the amounts of hydroxypropylmethylcellulose and polyethylene glycol in the fast-release exterior coating and intermediate coating, together with maltodextrin and warming sensate in the fast-release exterior coating.
Claims Coverage
The independent claim set covers coated oral dosage forms configured to provide a sensorial experience in the oral cavity, with four inventive feature groups totaling the core active composition and the layered fast-release and intermediate coating system.
Layered coated oral dosage form for sensorial experience
A coated oral dosage form that provides a sensorial experience in the oral cavity of the user, comprising a core and layered coatings including a fast-release exterior coating and an intermediate coating.
Defined core with acetaminophen, dextromethorphan, and phenylephrine
A core comprising between about 300 mg and about 400 mg acetaminophen, between about 5 mg and about 15 mg dextromethorphan, and between about 2.5 mg and about 7.5 mg phenylephrine.
Fast-release exterior coating with hydroxypropylmethylcellulose, polyethylene glycol, maltodextrin, and warming sensate
A fast-release exterior coating comprising between about 2 mg and about 6 mg hydroxypropylmethylcellulose and polyethylene glycol, between about 3 mg and about 5 mg maltodextrin, and between about 0.5 mg and about 2.5 mg warming sensate.
Intermediate coating providing a separate coating layer
An intermediate coating comprising between about 10 mg and about 20 mg hydroxypropylmethylcellulose and polyethylene glycol.
Collectively, the independent claims cover a coated oral dosage form that provides a sensorial experience in the oral cavity using a core with defined acetaminophen, dextromethorphan, and phenylephrine amounts and a layered coating system. The fast-release exterior coating includes hydroxypropylmethylcellulose, polyethylene glycol, maltodextrin, and warming sensate, while the intermediate coating comprises hydroxypropylmethylcellulose and polyethylene glycol as a separate layer.
Stated Advantages
Provides a sensorial experience in the oral cavity of the user.
Documented Applications
Treating symptoms of cold and/or flu and/or allergies by administering a coated oral dosage form as described in the claims to a human.
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