Patent ReferencesSustained-release pharmaceutical tablet and process for preparation thereof Multilayer sustained release granule Rotogranulations and taste masking coatings for preparation of chewable pharmaceutical tablets Multilayered controlled release pharmaceutical dosage form Powder-layered morphine sulfate formulations Multilayered controlled release pharmaceutical dosage form Method of treating pain by administering 24 hour oral opioid formulations exhibiting rapid rate of initial rise of plasma drug level Patent #: 5478577 InventorsAssigneeApplicationNo. 896629 filed on 07/18/1997US Classes:424/458, Containing discrete coated particles pellets, granules, or beads424/457, Sustained or differential release424/459, Organic coatings424/461, Containing polysaccharide (e.g., cellulose sugars, etc.)424/462, Containing solid synthetic polymers424/468, Sustained or differential release type424/494, Cellulose derivatives424/495, Ethyl cellulose424/496, Containing natural gums/resins424/497, Containing solid synthetic polymers514/781, Cellulose or derivative514/782Natural gum or resinExaminersPrimary: Spear, James M.Attorney, Agent or FirmInternational ClassesA61K 009/22A61K 009/54 A61K 009/60 A61K 009/62 Foreign Application Priority Data1996-07-25 DEAbstractA multiple unit oral pharmaceutical dosage form having a plurality of pellets in a water soluble capsule or in a tablet compressed from the pellets, wherein each pellet contains (a) a substantially inert core, (b) an active ingredient layer over the inert core, and containing (i) a pharmacologically active particulate active ingredient, (ii) a nonembedding amount of a binder for adhering the active ingredient over the inert core, and optionally (iii) a pharmaceutically acceptable, inert adjuvant, such as colloidal silica, and (c) a coating over the active ingredient layer for retarding the release of the active ingredient from the active ingredient layer into an aqueous body fluid solvent in situ, the nonembedding amount of the binder is suitably from about 1% wt. to about 10% wt. based on the active ingredient layer, the binder in the active ingredient layer is suitably a mixture of ethylcellulose and shellac, in a weight proportion suitably of from about 1:9 to about 9:1, the coating for retarding the release suitably contains from about 70% wt. to about 95% wt. based on the coating, of a substantially water-insoluble, pharmacologically inert, particulate material, and a binder; the pharmacologically inert, particulate material is suitably talcum, and the binder in the active ingredient layer is suitably identical to the binder in the coating.Field of SearchLayered unitary dosage formsContaining discrete coated particles pellets, granules, or beads Organic coatings Containing polysaccharide (e.g., cellulose sugars, etc.) Containing solid synthetic polymers Cellulose derivatives Ethyl cellulose Containing solid synthetic polymers Sustained or differential release Sustained or differential release type Containing natural gums/resins | |