Apparatus and method for preparing solid forms with controlled release of the active ingredient

• US 5,707,636 A
• Filed: 06/20/1996
• Issued: 01/13/1998
• Est. Priority Date: 08/03/1994
• Status: Expired due to Term

• Current Assignee: Future Trademark Technologies, LLC
• Original Assignee: Saitec S.R.L.
• Inventors: Rodriguez, Lorenzo, Motta, Giuseppe, Cini, Maurizio, Cavallari, Cristina
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): SIKHA, MURTHY
• Application Number:
  US08/624,475
• Time in Patent Office: 572 Days
• Field of Search: 424/401, 424/490, 424/405, 424/408, 424/409, 424/489, 424/497, 204/157.15, 204/157.62, 118/57, 118/300, 118/612, 118/639, 118/654, 118/DIG. 5, 427/475, 427/478, 427/480, 427/2.15
• US Class Current: 424/401
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: B01J 2/04 in a gaseous medium if combined with suspending the material in a gas, e.g. fluidised beds B01J2/16
• CPC Class Codes: B01J 2/18 using a vibrating apparatus

Abstract

Controlled release solid forms, apparatus and method for preparing solid forms for controlled release of an active ingredient.

Claims

1. Apparatus for preparing solid forms with controlled release of the active ingredient according to the spray drying and spray congealing techniques, characterized in that is comprises:

a) an atomizing device utilizing mechanical vibrations of resonant metal elements or nozzles, that nebulizes in very little droplets a liquid comprising a solution, suspension or emulsion of one or more active ingredients and/or excipients in one or more solvents of different polarity or of one or more active ingredients in one or more melted waxy excipients;

b) a cylindrical chamber with vertical axis inside of which the droplets thus obtained in a) fall to give spherical powder particles because of the evaporation of the contained solvents or of the solidification owing to the quenching of the melted waxy components, and

c) a device for recovering the volatile solvents eventually employed.

2. Apparatus according to claim 1, characterized in that the resonant metal elements comprise appropriately shaped sonotrodes or with application of vibrating elements, for example thin plates, or provided with a nozzle the diameter of which depends on the liquid to be treated.

3. Apparatus according to claim 1, characterized in that the diameter of the droplets obtained in a) is of from 5 to 500 microns.

4. Apparatus according to claim 1, characterized in that the length of the atomized fluid jet is usually of from 25 to 30 cm with a loading of 50 l/h.

5. Apparatus according to claim 1, characterized in that the atomization chamber heigth b) is usually lower than 2 m and the diameter is of 1 m.

6. Apparatus according to claim 1, characterized in that the mechanical frequencies are of from 20 kHz to 150 kHz.

7. Method for preparing solid forms with controlled release of the active ingredient, characterized in that a suspension, solution or emulsion of one or more active ingredients and/or excipients in one or more solvents of different polarity or of one or more active ingredients in one or more melted waxy excipients is fed on resonant metal elements or nozzles subjected to infrasonic, sonic or ultrasonic frequencies, the very small droplets thus obtained fall in a cylindrical chamber with vertical axis to give spherical powder particles, and the solvents eventually employed are recovered.

8. Method according to claim 7, characterized in that the solution, suspension or emulsion fed to the resonant metal elements is an aqueous composition.

9. Method according to claim 7, characterized in that the solution, suspension or emulsion is fed to the resonant metal elements or nozzles in an amount of at least 50 l/h.

10. Method according to claim 7 or 8, characterized in that as resonant metal elements appropriately shaped sonotrodes or with application of vibrating elements, for example thin plate, or provided with a nozzle are employed.