GB2438166A

GB2438166A - Carrier matrix with pharmaceutical active component and recognition part

Info

Publication number: GB2438166A
Application number: GB0703746A
Authority: GB
Inventors: Thomas Brian Chapman
Original assignee: Essential Nutrition Ltd
Current assignee: Essential Nutrition Ltd
Priority date: 2006-03-03
Filing date: 2007-02-27
Publication date: 2007-11-21
Also published as: GB0604299D0; GB0703746D0

Abstract

A pharmaceutical product consisting of a carrier matrix, a pharmaceutically active component carried in, on or by the carrier matrix, and a discrete self-supporting body is carried in, on or by the carrier matrix, where at least a part of the discrete self-supporting body is routinely incapable of visual recognition and is rendered capable of sensory recognition instrumentally. Where the pharmaceutical product is a controlled drug for treating an addiction and where the sensory recognition can be light reflective, luminous, luminescent, chemiluminescent, electrochemiluminescent, fluorescent, phosphorscent, UV light reflective, magnetic, magnetic field distorting or radio frequency reflective. Or the instrument for recognition of the kit can be a magnifying instrument.

Description

DEVICE

The present invention relates to a pharmaceutical product.

Pharmaceutical product fraud is a major problem in the pharmaceutical industry.

A first type of pharmaceutical product fraud is counterfeiting. Counterfeiters make counterfeit products which resemble proprietary pharmaceutical products but have no active ingredient. This can be dangerous for the patient as the counterfeit may have either no beneficial effect or an adverse effect. A pharmaceutical manufacturer marketing the authentic product may suffer loss of sales or damage to goodwill and reputation by negative publicity surrounding the counterfeit products. It is estimated that this type of fraud costs the pharmaceutical industry worldwide around $8 billion per year.

A second type of pharmaceutical product fraud is unauthorised reselling. An example of unauthorised reselling occurs when a first addict is prescribed by a prescribing organisation (such as a hospital addiction clinic) a controlled drug to treat an addiction and re-sells the prescribed controlled drug to a second addict. * *

Previously in both types of pharmaceutical product fraud, detection relied on laboratory analysis of the suspect product. The suspect product is authenticated if the *:* composition of the suspect product matches the specified composition of the authentic product. Such an analysis is slow and expensive. Furthermore, authentication by * * composition analysis may fail to distinguish between different batches of the same :: pharmaceutical product. Therefore not all instances of unauthorised reselling can be * detected by this technique.

Thus viewed from one aspect the present invention provides a pharmaceutical product comprising: a carrier matrix; a pharmaceutically active component carried in, on or by the carrier matrix; and a discrete self-supporting body carried in, on or by the carrier matrix, wherein at least a part of the discrete self-supporting body is routinely incapable of visual recognition and is rendered capable of sensory recognition instrumentally.

The present invention advantageously allows an authorised body to authenticate a suspect pharmaceutical product without analytical laboratory testing. As the discrete self-supporting body (at least in part) of an authentic product is incapable of visual recognition during routine use, a counterfeiter will fail to replicate it in a counterfeit product. A simple instrumental test to recognise the discrete self-supporting body will allow the authorised body to distinguish an authentic product from a counterfeit product.

The pharmaceutically active component may be therapeutically active, prophylactically active or performance enhancing (eg mind or body enhancing).

Preferably the pharmaceutically active component comprises a controlled drug for treating an addiction. For example, the pharmaceutically active component may comprise Dihydrocodeine. * **

The carner matrix may be a chemical carrier matrix. For example, a chemical S...

carrier matrix may serve to define a solid or liquid formulation of the pharmaceutically E active component. The formulation may be a solution, suspension, colloid, emulsion, * S powder (eg a compressed or uncompressed powder), syrup or gel. The chemical carrier * matrix may be or comprise one or more solvents, surfactants, coatings, excipients, diluents, :: colourants, flavourings, gefling agents, stabilisers or emulsifiers. The pharmaceutically active component carried in, on or by the chemical carrier matrix may define a suitable dosage form such as a tablet, pill, capsule, ointment, injection, drop, tincture, cream or liniment. Preferably the phannaceutically active component carried in, on or by the chemical carrier matrix may define a tablet.

Where the chemical carrier matrix is a compressed powder (eg in the form of a tablet), the discrete self-supporting body may be embedded in the compressed powder.

Typically the discrete self-supporting body is introduced into the pre-compressed powder by titration.

Where the chemical carrier matrix is or comprises a coating, the discrete self-supporting body may be incorporated in or attached to the coating. The discrete s self-supporting body may be attached to the coating by a lacquer, varnish or glue. The coating may be polymeric. The coating may be a sugar coating. The coating may be a seal coating.

The carrier matrix may be or comprise a mechanical carrier matrix.

The carrier matrix may comprise a chemical carrier matrix as hereinbefore defined and a mechanical carrier matrix. A first discrete self-supporting body may be carried in, on or by the mechanical carrier matrix and a second discrete self-supporting body may be carried in, on or by the chemical carrier matrix.

In a preferred embodiment, the mechanical carrier matrix is packaging. The packaging may have discrete (eg separable) primary and secondary packaging elements.

; Examples of suitable packaging elements are a blister pack, sachet, box or packet. The discrete self-supporting body may be mechanically or chemically (eg adhesively) attached to the packaging. The discrete self-supporting body may be attached to the packaging by a lacquer, varnish or glue. The discrete self-supporting body may be suspended in a lacquer, * varnish or glue and applied to the packaging by spraying (eg using a spray gun). * 0% * .

The discrete self-supporting body may be in form of a disc or bead. Preferably the discrete self-supporting body is a disc. Preferably the discrete self-supporting body is a microdot.

in a preferred embodiment, the at least a part of the discrete self-supporting body is rendered capable of visual recognition instrumentally. Particularly preferably the at least a part of the discrete self-supporting body is rendered capable of visual recognition instrumentally by magnification.

The discrete self-supporting body may be routinely invisible to the naked eye. The discrete self-supporting body may be rendered visible to the naked eye by a magnifying instrument (eg a magnifying glass). Preferably the magnifying instrument is capable of magnification by 30 times or more.

The discrete self-supporting body may be rendered capable of sensory recognition instrumentally by being light reflective, luminous, luminescent, chemiluminescent, electrochemilumjnescent, fluorescent, phosphorescent, UV light reflective, magnetic, magnetic field distorting or radio frequency reflective.

The discrete self-supporting body may be soluble or insoluble. Preferably the discrete self-supporting body is insoluble. The discrete self-supporting body may be digestible or indigestible. The discrete self-supporting body may be physiologically tolerable. The discrete self-supporting body may be polymeric.

The discrete self-supporting body may be 2mm or less in diameter. Typically the discrete self-supporting body is 1.5mm or less in diameter. Preferably the discrete Is self-supporting body is between 0. 4mm and 1.5mm in diameter. Particularly preferably the discrete self-supporting body is between 0.8mm and 1.2mm in diameter. Especially preferably the discrete self-supporting body is approximately 1mm in diameter. * . * 0S*

*.::* In a preferred embodiment, the part of the discrete self-supporting body which is * routinely incapable of visual recognition and rendered capable of sensory recognition : 20 instrumentally is an indicia. The indicia may be or comprise one or more of an image, a * marking, an etching, a numeral or text. Preferably the indicia is at least partly numerical.

* * Preferably the indicia is at least partly textual (eg lettering). ** * * * S * S*

Typically the indicia is unique to a characteristic of the pharmaceutical product.

In a preferred embodiment, the indicia is unique to the manufacturer of the pharmaceutical product.

In a preferred embodiment, the indicia is unique to a manufactured batch of the pharmaceutical product.

In a preferred embodiment, the indicia is unique to a prescribee of the pharmaceutical product. In a preferred embodiment, the indicia is unique to a batch prescription of the pharmaceutical product. These embodiments may advantageously allow an authorised body to determine if a suspect product has been resold without authorisation.

For example, the authorised body may want to determine whether a drug addict has obtained a prescribed addiction treatment such as Dihydrocodeine legally or illegally. An unauthorised reseller will be unable to see that the prescribed batch he has resold to a third party is capable of authentification.

In one embodiment, the pharmaceutical product comprises a plurality of discrete self-supporting bodies of the type hereinbefore defmed.

Viewed from a further aspect, the present invention provides a pharmaceutical product comprising: a carrier matrix; a pharmaceutically active component carried in, on or by the carrier matrix; a first discrete self-supporting body carried in, on or by the carrier matrix, wherein at least a part of the first discrete self-supporting body is routinely incapable of visual *:::* recognition and is capable of visual recognition of a first type instrumentally; and a second discrete self-supporting body carried in, on or by the carrier matrix, wherein at least a part of the second discrete self-supporting body is routinely incapable of visual recognition and is capable of visual recognition of a second type instrumentally. * . * S * * **

* :* : The visual recognition of a first type and the visual recognition of a second type may be the same or different. Preferably the visual recognition of a first type and the visual recognition of a second type are different. Particularly preferably the part of the first discrete self-supporting body and the part of the second self-supporting body comprise different indicia. More preferably the first discrete self-supporting body is carried in, on or by a first part of the carrier matrix and the second discrete self-supporting body is carried in, on or by a second part of the carrier matrix, wherein the first part of the carrier matrix and the second part of the carrier matrix are discrete (eg separable). The first part of the carrier matrix may be a first mechanical part of the carrier matrix (eg a first packaging element such as a box) and the second part of the carrier matrix may be a second mechanical part of the carrier matrix (eg a second packaging element such as a blister pack). A unique combination of different indicia (eg batch numbers) on (for example) a blister pack and a box advantageously increases the difficulty for a counterfeiter to identify a suitable indicia (eg batch number) combination which would not be revealed as counterfeit.

Viewed from a yet further aspect the present invention provides a kit of parts comprising: a pharmaceutical product as hereinbefore defined; and an instrument capable of rendering capable of sensory recognition the part of the is (or each) self-supporting body which is routinely incapable of visual recognition.

The instrument may utilise visible light, ultraviolet light, magnetic radiation or radio frequency radiation to read the indicia. Preferably the instrument is a magnifying instrument such as a microscope or magnifying glass. Preferably the magnifying instrument is capable of magnification by 30 times or more. *.S.

* .2o The instrument may be an indicia reader. * *

The present invention will now be described in a non-limitative sense wIth *.* reference to the following example. * . S. * * ..

Example

Dihydrocodeine slow release tablets used medically as a substitution therapy for drug addicts are made in a batch from the following ingredients: Dihydrocodeine EP 240mg -7..

Talc EP 2mg Maltodextrin EP 240mg Hydroxypropyl methylcellulose K4M 100mg Magnesium Stearate EP 5mg S Microdot 2mg The weights refer to the average amount of ingredient per 589mg tablet.

Method of Manufacture The microdots are carefully weighed and to them are added the same amount of talc. The mixture is mixed in a small blender for 15 minutes. The mixture is transferred to a larger mixer and the same amount of Maltodextrin is added and this is mixed for 5 minutes. An amount of Maltodextrin equivalent to the total mass of the last mix is added and this is mixed for 5 minutes.

Using this doubling up technique, all of the ingredients except Magnesium Stearate are added and mixed in. This method ensures even dispersal of the microdots at a rate of approximately 20 microdots per tablet.

Finally Magnesium Stearate is added and mixed for 3 minutes. This ensures that the granules are coated with the lubricant externally. * . S..

* *: A Manesty D4 compression machine is set up with specific tooling and tablets are 1* pressed at a weight of 589mg and tolerance 585mg to 592mg.

After pressing, the tablets are checked using BP methods for weight compliance, hardness and disintegration/dissolution and then for presence of microdots by breaking open a tablet and examining under a 30x magnification reader.

After normal assay methods for identification of active components and assay of the active components the tablets are released for coating.

During coating a seal coat is manufactured containing several grades of cellulose such as HPMC and HMC in a suitable solvent.

Two milligrammes of microdots are added to this solution and the tablets are sealed using heat and extraction in a coating pan revolving at 18 r.p.m.

Afier seal coating a proprietary coating solution is prepared and a further amount of dihydrocodeine is added to this solution together with 2mg of microdots per tablet.

This coating is sprayed onto the tablets using a Schlit' spray gun until the tablets gain a weight equivalent to the 30mg dihydrocodeine. The tablet is then dried overnight and in the morning is put back into a polishing pan where 15cc per kilo of OPAGLOS polishing solution is added.

The pan is rotated until a final polish appears on each tablet and the tablet is returned to quality control laboratories for testing as before.

In the packing area the tablet is placed in a NOAK 740 DPN form, fill and seal machine where it is blister packed by forming a hole in 200 micro PVDC film and adding one tablet to each hole. The hole is then lidded by heating and rolling a 20 micro film of hard tempered aluminium foil over the hole. The aluminium foil is printed with the name S...

of the tablet and then varnished and the varnish incorporates more microdots. S. S * . .

The blister strips so formed are machine cut and inserted into a carton for sale and *...

during the printing and varnishing of the carton further microdots can be incorporated in thevarnish. S. * * * * * S.

Claims

CLAIMS

1. A pharmaceutical product comprising: a carrier matrix; a pharmaceutically active component carried in, on or by the carrier matrix; and a discrete self-supporting body carried in, on or by the carrier matrix, wherein at least a part of the discrete self-supporting body is routinely incapable of visual recognition and is rendered capable of sensory recognition instrumentally.
2. A pharmaceutical product as claimed in claim 1 wherein the at least a part of the discrete self-supporting body is rendered capable of visual recognition instrumentally.
3. A pharmaceutical product as claimed in claim I or 2 wherein the carrier matrix comprises a chemical carrier matrix.
4. A pharmaceutical product as claimed in claim 3 wherein the chemical carrier matrix serves to define a solid formulation of the pharmaceutically active component.
5. A pharmaceutical product as claimed in claim 3 wherein the chemical carrier matrix serves to define a liquid formulation of the pharmaceutically active component. e*..
6. A pharmaceutical product as claimed in claim 3 wherein the chemical carrier * matrix comprises one or more solvents, surfactants, coatings, excipients, diluents, * colourants, flavourings, gelling agents, stabilisers or emulsifiers. ***

*.*:.*
7. A pharmaceutical product as claimed in any of claims 1 to 3 wherein the pharmaceutically active component carried in, on or by the carrier matrix defines a tablet.
8. A pharmaceutical product as claimed in any of claims I to 3 wherein the carrier matrix further comprises a mechanical carrier matrix.
9. A pharmaceutical product as claimed in claim 8 wherein the mechanical carrier matrix comprises packaging.
10. A pharmaceutical product as claimed in any preceding claim wherein the discrete self-supporting body is in form of a disc or bead.
11. A pharmaceutical product as claimed in any preceding claim wherein the discrete self-supporting body is rendered capable of sensory recognition instrumentally by being light reflective, luminous, luminescent, chemiluminescent, electrochemiluminescent, fluorescent, phosphorescent, UV light reflective, magnetic, magnetic field distorting or radio frequency reflective.
12. A pharmaceutical product as claimed in any preceding claim wherein the discrete self-supporting body is 2mm or less in diameter.
13. A pharmaceutical product as claimed in any preceding claim wherein the part of the discrete self-supporting body which is routinely incapable of visual recognition and rendered capable of sensory recognition instrumentally comprises an indicia.
14. A pharmaceutical product as claimed in claim 13 wherein the indicia is unique to : .. * a characteristic of the pharmaceutical product. * * S...
15. A pharmaceutical product as claimed in claim 13 wherein the indicia is unique to * the manufacturer of the pharmaceutical product.

S
16. A pharmaceutical product as claimed in claim 13 wherein the indicia is unique to * a manufactured batch of the phannaceutical product.
17. A pharmaceutical product as claimed in claim 13 wherein the indicia is unique to a prescribee of the pharmaceutical product.
18. A pharmaceutical product as claimed in any preceding claim wherein the pharmaceutical product comprises a plurality of discrete self-supporting bodies.
19. A phannaceutical product comprising: a carrier matrix; a pharmaceutically active component earned in, on or by the carrier matrix; a first discrete self-supporting body carried in, on or by the carrier matrix, wherein at least a part of the first discrete self-supporting body is routinely incapable of visual recognition and is capable of visual recognition of a first type instrumentally; and a second discrete self-supporting body carried in, on or by the carrier matrix, to wherein at least a part of the second discrete self-supporting body is routinely incapable of visual recognition and is capable of visual recognition of a second type instrumentally.
20. A pharmaceutical product as claimed in claim 19 wherein the visual recognition of a first type and the visual recognition of a second type are different.
21. A pharmaceutical product as claimed in claim 20 wherein the part of the first discrete self-supporting body and the part of the second self-supporting body comprise different indicia.

:...
22. A pharmaceutical product as claimed in any of claims 19 to 21 wherein the first e.

discrete self-supporting body is earned in, on or by a first part of the carrier matrix and the * :*: second discrete self-supporting body is carried in, on or by a second part of the carrier * 20 matrix, wherein the first part of the carrier matrix and the second part of the carrier matrix *.*.

are discrete * * * * * * ** * .
23. A pharmaceutical product as claimed in any preceding claim wherein the pharmaceutically active component comprises a controlled drug for treating an addiction.

24. A kit of parts comprising: a pharmaceutical product as defined in any preceding claim; and an instrument capable of rendering capable of sensory recognition the part of the (or each) self-supporting body which is routinely incapable of visual recognition.

25. A kit of parts as claimed in claim 19 wherein the instrument is a magnifying instrument. * S * **S **** * * **** ** S * S S * **

S S...

S * * * S S * ** S. S

S S S * SS