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Pharmaceutical formulations

IP.com Disclosure Number: IPCOM000215458D
Publication Date: 2012-Feb-29
Document File: 3 page(s) / 81K

Publishing Venue

The IP.com Prior Art Database

Abstract

Pharmaceutical compositions of several strengths are provided.

This text was extracted from a Microsoft Word document.
This is the abbreviated version, containing approximately 36% of the total text.

Pharmaceutical formulations

The following are formulations of the compound finally obtained in example 3 of ES2165857. This compound will be referred to here as ‘Compound 1’.

The formulations are prepared using the following manufacturing process:

Compound 1 and one or more of the following excipients:

CaH2PO4

CaCO3

Maltodextrin

Sodium croscarmelose

Lactose

Corn starch

Pregelatinized starch

are sieved though a medium sized sieve and are homogenised. This forms blend 1.

One or more of the following excipients, if present:

Talc

Colloidal silicon dioxide

are sieved though a medium sized sieve and are homogenised. This forms blend 2.

Blend 1 and blend 2 are mixed and homogenized forming the final mixture. The final mixture is encapsulated into suitable gelatine capsules.

CaH2PO4 is meant to be powdered CaH2PO4, granulated CaH2PO4 or a mixture thereof.

Lactose is meant to be anhydrous lactose, monohydrate lactose or its mixtures.

The skilled in the art understands that all the combinations of the different possibilities are disclosed herein. Among said combinations are: powdered CaH2PO4 and anhydrous lactose, powdered CaH2PO4 and lactose hemihydrate, powdered CaH2PO4 and mixture of anhydrous and hemihydrate lactose, granulated CaH2PO4 and anhydrous lactose, granulated CaH2PO4 and lactose hemihydrate, granulated CaH2PO4 and mixture of anhydrous and hemihydrate lactose, mixture of powdered and granulated CaH2PO4 and anhydrous lactose, mixture of powdered and granulated CaH2PO4 and lactose hemihydrates and mixture of powdered and granulated CaH2PO4 and mixture of anhydrous and hemihydrate lactose.

The pharmaceutical compositions prepared have the following composition in percentage by weight:

Example

1

2

3

4

5

6

7

8

Compound 1

25,00

25,00

25,00

25,00

25,00

25,00

25,00

25,00

Talc

20,00

20,00

20,00

20,00

20,00

20,00

20,00

20,00

Lactose

35,00

27,30

18,00

--

--

--

--

--

Corn starch

20,00

--

--

55,00

--

--

--

27,30

Pregelatinized starch

--

--

--

--

55,00

--

--

--

CaH2PO4 anhydrous

--

27,50

36,80

--

--

55,00

--

27,50

CaCO3

--

--

--

--

--

--

54,80

--

Colloidal silicon dioxide

--

0,20

0,20

--

--

--

0,20

0,20

Maltodextrin

--

--

--

--

--

--

--

--

Sodium croscarmelose

--

--

--

--

--

--

--

--

Formula

A

A

A

A

A

A

A

A

Example

9

10

11

12

13

14

15

16

Compound 1

25,00

25,00

25,00

25,00

25,00

25,00

25,00

25,00

Talc

20,00

20,00

20,00

20,00

20,00

20,00

20,00

20,00

Lactose

--

--

--

--

--

--

27,50

18,00

Corn starch

--

41,50

16,50

--

--

--

--

--

Pregelatinized starch

--

--

--

--

--

--

--

--

CaH2PO4 anhydrous

--

13,30

13,30

44,80

49,80

45,00

27,50

37,00

CaCO3

--

--

--

--

--

--

--

--

Colloidal silicon dioxide

0,20

0,20

0,20

0,20

0,20

--

--

--

Maltodextrin

54,80

--

--

--

--

--

--

--

Sodium croscarmelose

--

--

25,00

10,00

5,00

10,00

--

--

Formula

A

A

A

A

A

A

A

A

Example

17

18

19

20

21

22

23

24

Compound 1

25,00

25,00

25,00

25,00

25,00

25,00

25,00

25,00

Talc

--

--

10,00

10,00

10,00

15,00

15,00

15,00

Lactose

27,50

18,00

10,00

--

10,00

10,00

--

7,50

Corn starch

--

--

27,50

41,...