Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1996-06-17
1997-09-23
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424 113, 424434, A61K 920
Patent
active
056701675
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/GB94/02214 dated Oct. 10, 1994.
This invention relates to a novel process for the production of a compacted body of powdered medicament, especially powdered inhalation medicament, referred to herein as a "medicament compact", of the type disclosed in European Patent 407028.
The administration by inhalation of medicaments in dry powder form is well known. Devices for the metering and dispensing of measured doses of medicament from a reservoir have also been described previously, for example, in UK Patent No. 2041763 and U.S. Pat. No. 2,587,215. Such devices typically comprise a medicament reservoir and a metering chamber with a volume chosen such that, when filled, the chamber contains the desired weight of medicament for one dose. Filling of the metering chamber is generally accomplished under the influence of gravity, the chamber typically being located at the bottom of the reservoir. Such devices have the disadvantage that variations in the density of the metered powder can easily occur resulting in inaccurate or inconsistent dosing. The packing density of the powder may also depend on the weight of powder remaining in the reservoir, leading to a gradual reduction in the dose delivered by the device. In addition, the dose metered is strongly dependent on the orientation of the device.
European Patent 407028 discloses a device which overcomes the disadvantages of other dry powder devices by the use of a metering means which relies not on gravitational force to fill a metering chamber, but on abrasion of a compacted body of powdered medicament. This application contemplated the use of hydraulic presses and the like in the production of the medicament compacts.
Since the device of European Patent 407028 (in which the medicament compacts are adapted for use) functions by abrading a fixed volume of the medicament compact, it is important that the density of medicament throughout the compact is as uniform as possible. If the density is uniform then slices of medicament of the same thickness abraded from the compact will contain the same amount of medicament, thus ensuring that the correct dosage of medicament is consistently administered to a patient.
Compacted bodies of powdered inhalation medicament are also disclosed in International Patent Applications WO 93/24165 and WO 94/14490. The later application (published after the priority date of the present application) contemplates methods involving isostatic compression of elastic matrices, injection moulding of plastified masses, melting processes and pressure diecasting for the production of such compacted bodies.
International Patent Application WO 94/00291, published after the priority date of the present application, describes a process for making annular compacted bodies of powdered medicament which involves the radial compaction of loose powdered medicament using an expanding mandrel.
We have now found a novel process for the production of medicament compacts which allows for the production of medicament compacts having a more uniform density than compacts produced by prior art processes and which overcomes or substantially mitigates the problems encountered in processes known from the prior art.
According to the invention we provide a process for the production of a medicament compact, which comprises the steps of: longitudinal axis such that during compression the frictional force between the medicament and the mould and the frictional force between the medicament and the mandrel are in opposite directions parallel to the longitudinal axis.
Steps a) and b) may be performed in either order or simultaneously, however, we prefer the mandrel to be positioned along the longitudinal axis of the mould after the medicament has been placed in the mould. Positioning the mandrel along the longitudinal axis of the mould after the powder has been added ensures an even distribution of powder around the mandrel, placing the powder in the mould after the mandrel has been inserted is less likely to give an even distribution of powder.
REFERENCES:
patent: 3189942 (1965-06-01), Rapprich
Anson Paul Manuel
Dyson Hugh William
Sleath Clive Roland
Benston, Jr. William E.
Fisons plc
Oehler Ross J.
Page Thurman K.
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