AU605538B2 - Pharmaceutical unit - Google Patents

Description

5434-Pl/HC/RP/0378T/*. *t AUSTRaL IA PATENTS ACT 1952 'r COMPLETE SPECIFICATION b

(ORIGINAL)

FOR OFFICE USE Application Number: Loaged: Complete Specification Lodged: Accepted: Published: am2A2

(S

a i -ti Priority: Related Art: TO BE COMPLETED BY APPLICAN~T 0000 0 00 0 0 0 0000 0000 0 0 0000 000000 0 0 Name of Applicant: Address of Applicant: ADCOCK- INGRAM LABORATORIES

LIMITED

Adcock-Ingram House, 105 Quartz Street, HillbroW, ,Johannesburg, Transvaal, SOUTH

AFRICA

BINIOMIN KRENGEL ARTHUR S. CAVE CO.

Patent Trade Mark Attorneys Level Barrack Street SYDNEY N.S.W. 200U

AUSTRALIA

Actual. Inventor: Address for Service: 0 00 0 0 0 0 00 0 00 0 0 0 0000, 0 0 0 00 060O000 0 0 Complete Specification for the invention entitled "PHARMACEUTICAL UNIT".

The following statement is a full description of this invention including the best method of performing it known to me:- 1- ASC 49 I Sydney

I

6 i Sf: 2 c c ~cc BACKGROUND OF THE INVENTION This invention relates to pharmaceutical units.

There are many anti-inflammatory compounds presently on the market.

Among these compounds may be mentioned indomethacin, flubiprofen, ketoprofen, ibuprofen, fenoprofen, indoprofen, fenbufen and naproxen.

These compounds are used primarily for their anti-inflammatory propcrties, although some of them do exhibit other useful therapeutic indications.

The literature contains reports on clinical studies involving administering ibuprofen or flubiprofen with paracetamol or aspirin as a supplemental analgesic.

i"" 3 SUMMARY OF THE INVENTION According to the invention, there is provided a dose least two pharmaceutical units, each unit containing ibuprofen and at least one analgesic agent as active dose providing a therapeutically effective amount of ingredient.

comprising at a combination of ingredients, the each active 0000 0 0 ooo 00 0 00 0 0 00 o o ooo O0 0 0 It is an essential aspect of the invention that each dose, that is the amount which is administered to a warm-blooded animal such as a human at any given time, provides a therapeutically effective amount of both active ingredients. Thus, the dose will produce both antiinflammatory and analgesic effects in the animal to which it is administered.

The units will generally be in orally administrable form and will typically be in the form of tablets, capsules or a quantity of liquid.

DETAILED DESCRIPTION OF THE INVENTION Where a single analgesic agent is used in the units, that agent is preferably paracetamol. Where more than one analgesic agent is used in the units, the agents are preferably paracetamol and codeine. The codeine, when used, may be used in the form of the base or a pharmaceutically-acceptable salt, e.g. the phosphate or sulphate salt. The paracetamol, when used, provides the composition with anti-pyretic properties as well.

Several doses will generally be administered per day so as to provide a warm-blooded animal with 800 to 200mg of ibuprofen and 1000 to 2500mg of analgesic per day. Thus, for example, the units may be 0 tc tc Cc O cc C CC' C cc O C"" O CC

I--

-4provided in the form of tablets each containing 200mg of ibuprofen and 250mg of paracetamol. Two tablets may be taken four times daily to provide the desired daily dose of ibuprofen and paracetamol.

Examples of the invention will now be described.

EXAMPLE 1 Tablets containing ibuprofen as anti-inflammatory agent and paracetamol and codeine as analgesic agents were produced. Each tablet contained the ingredients set out below: .4444~ 10

C

EC C CcC Ingredient Paracetamol Ibuprofen Codeine Binders Diluents Disintegrant Lubricant Core Weight Quantity per Tablet 250 170 5- 5- 5- 0,5 0,5 460 mg mg mg of core weight of core weight of core weight of core weight mg Ce C c CC The tablet cores were formulated by conventional prcedures, and then each tablet core was coated with a sugar coating, colouring agents, a binder, a lacquer and polishing aids. Alternatively, a conventional solvent or water-based film coat may be applied to the tablet core.

These tablets are suitable for the treatment of injury caused by excessive prostaglandin acitivity by oral administration of at least two tablets four times a day.

11 t m: L EXAMPLE 2 Capsules containing ibuprofen as anti-inflammatory agent, and paracetamol and codeine as analgesic agents were produced. Each capsule contained the ingredients set out below: Ingredient Quantity per Capsule Paracetamol Ibuprofen Codeine Binder/Diluents 250 300 mg 170 230 mg 5 30 mg 0,1 15 by weight of the total ingredients 0,1 2 by weight of the total ingredients

C

e Ce c c Lubricant The ingredients were mixed together by conventional rrocedures, and the mixture was then filled into Size 0 capsules.

The capsules are suitable for the treatment of injury caused by S excessive prostaglandin activity by oral administration of at least two capsules four times a day.

iC i t 6 EXAMPLE 3 A liquid containing ibuprofen as anti-inflammatory agent, and paracetamol and codeine as analgesic agents was produced. Each dose of the liquid contained the following ingredients: Ingredient Quantity per 30ml of the Liquid Cie 10 C V r 4 CC T

C

C C rC CCtl 15- Paracetamol Ibuprofen Codeine Solubilisers/ Stabilisers Cclouring Agents Alcohol Preservative 250 300 mg 170 230 mg 5 30 mg 15 40 by of 0,2 2 by of 4 18 by of 0,1 1 by weight of the liquid weight of the liquid weight of the liquid weight of the liquid The liquid was formulated by conventional procedures.

The liquid is suitable for the treatment of injury caused by excessive prostaglandin activity by oral administration of at least two tablespoons (30m.l) four times a day.

Claims (4)

1. A therapeutic composition for the treatment of acute inflammatory conditions resulting in pain comprising: a) ibuprofen in an amount of 170-230 mg; b) paracetamol in an amount of 250-300 mg; and, c) codeine in an amount of 5-30 mg.

2. A therapeutic compcsition as claimed in claim 1, dispensed in" the form of a tablet, a capsule or a quantity of liquid.

3. A therapeutic composition for the treatment of acute 0000 o" o inflammatory conditions resulting in pain, substantially as 0 00 o oo herein described with reference to any one of the Examples. 0000 0ooo

4. A method for treating acute inflammatory conditions 0 0oo resulting in pain utilising a therapeutic composition as herein described with reference to any one of the Examples. 6000 000 0000 0 0 DATED this 18th day of September,

1990. 6 O4 ADCOCK-INGRAM LABORATORIES LTD SC By Its Patent Attorneys ARTHUR S. CAVE CO. _1 _7-