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Orally administrable nifedipine pellet and process for the preparation thereof
| Details |
Inventors: Lee, Fang-Yu; Chen, Shan-Chiung; Kuo, Han-Chiang;
Assignee:
Primary Examiner: Page; Thurman K.
Assistant Examiner: Seidleck; Brian K.
Attorney, Agent or Firm: Chao; Fei-Fei Venable, Baetjer, Howard & Civiletti, LLP
The present invention relates to a fast-release as well as a prolonged release type of nifedipine pellets and the process for the preparation thereof. The fast-release type of nifedipine pellets comprises a particulate core which is covered by a nifedipine coating layer. The particulate core comprises water-soluble or water-insoluble excipient(s) and a pharmacologically acceptable carrier. The nifedipine coating layer comprises an effective amount of nifedipine dissolved in organic solvent(s). This nifedipine coating layer can further be mixed with a suspension which comprises an adhesive, an emulsifier, and a dispersant. The preferred composition of the fast-release type of nifedipine includes 20-70% of the particulate core, 3-15% of nifedipine, 1-20% of emulsifier, 1-20% of adhesive, and 1-30% of dispersant. The prolonged-release type of nifedipine pellets comprises, in addition to the particulate core and the nifedipine coating layer, a surface coating layer which is made of at lease one consisting of hydroxypropylcellulose, hydroxypropylmethylcellulose and ethylcellulose. This surface coating layer further comprises a plasticizer which is selected from the group consisting of triethylcitrate, triacetin, and diethyl phthalate. |
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DETAILED DESCRIPTION OF THE EMBODIMENTS A.
A Fast-Release Type of Nifedipine Pellet The fast-release type of nifedipine pellet described in this embodiment comprises: (1) a particulate core, and (2) a nifedipine coating layer.
The particulate core contains primarily an excipient and a pharmacologically acceptable carrier.
The excipient can be either water-soluble or water-insoluble.
The water-soluble excipient includes mannose, galactose, glucose, fructose, sucrose, lactose, maltose, dextrin, glycogen, and inulin.
The preferable water-soluble excipients are sucrose and lactose, although any water-soluble saccharides (alone or in any combination) can be used for this purpose.
The water-insoluble excipient(s) include, but not limited to, starch, microcrystalline cellulose, and talc.
These excipients can be used alone or together in any combination.
A detailed description of the formulas for making the particulate core containing water-insoluble excipients will be illustrated in (i) of Example 1 (infra).
The preferred pharmacologically acceptable carrier is sucrose.
A detailed description of the formulas for making the particulate core containing water-soluble excipients will be illustrated in (i) of Example 3 (infra).
The nifedipine coating layer comprises an effective amount of nifedipine.
Due to the insolubility of nifedipine in water, nifedipine must be dissolved in organic solvent.
Although nifedipine can be mixed with organic solvents such as acetone, alcohol, or isopropanol, it is preferable to dissolve nifedipine in an organic mixture containing acetone and alcohol in a ratio (vol/vol) of 1:1.
1 to 1:4.
A 0 to 30% by volume of distilled water can be added to this organic mixture.
The dissolved nifedipine (in organic solvent) is preferable to be further dispersed in an emulsified dispersing suspension which comprises at least an emulsifier, an adhesive, and a dispersant.
Emulsifier such as poloxamer 188, Tween 80, and sodium lauryl sulfate, adhesive such as polyvinylpyrrolidone, hydroxypropylcellulose, methylcellulose, and hydroxypropylmethylcellulose, dispersant such as lactose, sucrose, fructose, maltose, mannose, glucose, and polyethylene glycol (PEG) (with molecular weight of 4,000, 6,000, 8,000, and 20,000) can be mixed together in any combinations and amounts
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Weight Loss and Supplements 
