.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 8,871,273

« Back to Dashboard

Claims for Patent: 8,871,273

Title:Method for producing granules
Abstract: In a production process of granules containing a biologically active substance, variation in the elution profile of the biologically active substance is reduced by heating the temperature of granules to about 50.degree. C. or higher and maintaining the temperature for about 1 minute or longer. By setting the spray speed to about 90 mg/min or more per 1 g of cores when a spray agent for a primary agent containing the biologically active substance is sprayed while spraying a binding liquid to the cores and setting the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine to about 1.5 g/cm.sup.2 or more, the variation in the elution profile of the biologically active substance from the granules is reduced.
Inventor(s): Nagahara; Naoki (Osaka, JP), Asakawa; Naoki (Hikari, JP), Nonomura; Muneo (Osaka, JP)
Assignee: Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:11/884,498
Patent Claims: 1. A coated granule comprising a biologically active substance, obtained by a method that comprises steps of: (a) providing a granule comprising the biologically active substance and low substituted hydroxypropyl cellulose, wherein the biologically active substance is a benzimidazole proton pump inhibitor, (b) coating the granule comprising the biologically active substance with a coating material comprising a polymer base selected from the group consisting of low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, methyl cellulose, and hydroxyethylmethyl cellulose, so as to provide an intermediate coating layer on the granule (c) coating the granule obtained in the step (b) with a coating material comprising a mixture of two or more kinds of polymers selected from the group consisting of methyl methacrylate methacrylic acid copolymers, so as to provide a controlled release coating film on the granule, and (d) heating the granule comprising the biologically active substance to a temperature about 50.degree. C. or higher, and then maintaining the granule heated at the temperature for about 1 minute to about 1 hour, wherein the heating step is performed during the step (a), or during, before, or after the step (b) or the step (c), wherein the coated granule dissolves or elutes the biologically active substance, pH-dependently; and controls a release of the biologically active substance from the coated granule depending on pH to which the coated granule is exposed.

2. The coated granule according to claim 1, wherein the heating temperature of the granule is about 60.degree. C. or higher.

3. The coated granule according to claim 1, wherein the heating temperature of the granule is about 65.degree. C. or higher.

4. The coated granule according to claim 1, wherein the granule is maintained heated at the temperature for about 3 minutes to about 1 hour.

5. The coated granule according to claim 1, wherein the step of heating and maintaining the heat is performed before the coating step (b).

6. The coated granule according to claim 1, wherein the step of heating and maintaining the heat is performed during either of the coating steps (b) or (c).

7. The coated granule according to claim 1, wherein the step of heating and maintaining the heat is performed after either of the coating steps (b) or (c).
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc