Drug carrier pellet production process

1. A process for the production of drug carrier pellets comprising spray-drying a solution of a physiologically tolerable cellulosic binder, containing a physiologically tolerable inert particulate carrier having a particulate size D(v. 0.5) of less than 50 μm, and a filler selected from lactose, lactose monohydrate, sucrose, fructose, a fructooligosaccharide, inulin, mannitol, sorbitol, xylitol, inositol, isomalt or maltodextrin.

2. A process as claimed in claim 1 wherein said solution further contains an active drug substance.

3. A process as claimed in claim 1 or claim 2 wherein said carrier pellets are impregnated and/or coated one or more times.

4. A process as claimed in claim 3 wherein said carrier pellets are impregnated and/or coated with an active drug substance.

5. A process as claimed in claim 4 wherein said impregnated and/or coated pellets are further coated.

6. A process as claimed in claim 5 wherein said further coating is a release modifying coating.

7. A process as claimed in any one of claims 4 to 6 wherein said coatings are applied by fluidized bed coating.

8. A spray-dried pellet comprising a physiologically tolerable cellulosic binder, a physiologically tolerable inert particulate carrier having a particle size D(v, 0.5) of less than 50 μm and a filler selected from lactose, lactose monohydrate, sucrose, fructose, fructooligosaecharides, inulin, mannitol, sorbitol, xylitol, inositol, isomalt and maltodextrin.

9. The pellet of claim 8 wherein said cellulosic binder is a cellulose or cellulose derivative which is at least partially soluble in solvent or solvent mixture used for spray drying.

10. The pellet of claim 9 wherein said cellulosic binder is an alkylcellulose, a hydroxyalkylalkylcellulose, a hydroxyalkylcellulose or a carboxyalkylcellulose.

11. The pellet of claim 10 wherein said cellulosic binder is selected from methylcellulose, ethylcellulose, hydroxypropylmethylcellulose, hydroxycthylmethylcellulose, hydroxypropylcellulose and sodium carboxymethylcellulose.

12. The pellet of claim 8 wherein said cellulosic binder constitutes from 0.5-15% wt of said spray-dried pellets.

13. The pellet of claim 8 wherein said inert particulate carrier is a polymer, a clay or an inorganic carbonate, silicate, sulphate, phosphate or oxide.

14. The pellet of claim 13 wherein said inert particulate carrier is selected from activated carbon, kaolin, calcium carbonate, calcium silicate, calcium magnesium silicate, calcium lactate, calcium gluconate, calcium glycerophosphate, calcium phosphate, calcium hydrogen phosphate, calcium glucuronute, calcium aspartate, calcium glucoheptanoate, sodium hydrogen carbonate, sodium sulphate, magnesium sulphate, magnesium carbonate, barium carbonate, barium sulphate, and hydroxyapatites.

15. The pellet of claim 8 wherein said spray dried pellets further comprise at least one of an anti-foaming agent, and an active drug substance, or a mixture of two or more thereof.

16. The pellet of claim 15 having said active drug substance contained or, impregnated therein or coated thereon.

17. The pellet of claim 8 further coated with a release modifying coating.

18. The pellet of claim 8 having a D(v, 0.5) of 25 to 500 μm and a span value of no greater than 2.5.

19. The pellet of claim 8 having a robustness value (Rv) of no more than 40.

20. A pharmaceutical composition comprising a spray-dried pellet as claimed in claim 8 containing, impregnated with or coated with an active drug substance and optionally further comprising at least one pharmaceutically acceptable carrier or excipient.

21. A composition as claimed in claim 20 in tablet, coated tablet or capsule form.