GB2380937A

GB2380937A - Method of dispensing a plurality of medical substances into capsules

Info

Publication number: GB2380937A
Application number: GB0125064A
Authority: GB
Inventors: David Ian Slovick
Original assignee: Individual
Current assignee: Individual
Priority date: 2001-10-18
Filing date: 2001-10-18
Publication date: 2003-04-23
Also published as: EP1476118A1; WO2003032891A1; GB0408460D0; GB0125064D0; EP1476118B1; ATE534366T1; GB2397763A; ES2377516T3

Abstract

A single capsule is filled by a pharmacist with a plurality of active substances, the combination of the active substances and their dosage being as individually prescribed for the patient by the medical practitioner. Preferably, the individual active substances are formulated into micro-spherical dose-forms and the capsules are preferably marked with a code to identify the contained active ingredients and their dosage. In another aspect, a device for the filling of capsules with drug micro-spheres, said device comprising a loading station for receiving a canister containing micro-spheres of active substances, counting means and an outlet for introducing the counted micro-spheres into a capsule. Preferably, the device comprises capsule-sealing means, means for filling the capsules with inert gas and can print labels onto the capsules.

Description

METHOD OF DISPENSING PHARMACEUTICAL SUBSTANCES Field of the invention The present invention relates to the field of packaging and dispensing pharmaceutical formulations.

Background of the invention Medicinal dosage forms (such as tablets or capsules) contain an active substance present in micro-or milli-gram amounts combined with inactive substances which promote physical or chemical stability, ease of handling and identification of the product.

Current European guidance prefers that tablets be sold in'original dispensing packs'consisting of a metal foil laminated onto a plastic'blister'sheet, containing a one month supply of individual tablets, affording a useful shelf life.

Patients with serious conditions such as ischaemic heart disease or congestive heart failure are required to take daily a large number of medications, which frequently results in a failure to comply accurately with the recommended prescription. This can be due to: * forgetting pills * confusion with dosing schedules w unwillingness or fear of consuming large numbers of pills * errors in taking medications resulting in running out of some pills before others.

A formal study has shown patients'encash' prescriptions given by medical practitioners at local pharmacies for approximately 60% of the calculated total necessary number of pills, when given a regular prescription

of one single tablet daily. When the prescription is for two pills daily, the encashment figure can fall to only 15%.

Taking a sub-optimal number of pills would adversely affect quality of life and also reduce survival prognosis, since many treatments are life-extending, particularly when used in combination.

To mitigate this problem, it has previously been suggested that blister packing be offered as a free service by dispensing pharmacists, putting a number of tablets together in a day-coded package. However, patients are still faced with the same large number of tablets to take, which discourages them from taking their treatment reliably.

Blister packing is currently performed by only a few dispensing pharmacists as a special service, and is not widely available.

It has also been proposed to manufacture tablets containing fixed dose combinations of two or more active substances. This proposal suffers from the disadvantage that fixed dose combination tablets (typically of two active substances) are recommended only for patients who have previously been stabilised on the individual components. Any particular fixed dose combination made by a manufacturer might be unsuitable or harmful for some patients, by causing metabolic disturbances or excessive or inadequate effects.

Object of the invention The present invention therefore seeks to reduce the total number of dose forms ('pills') that patients are required to take daily.

Summary of the invention In its broadest aspect, the present invention provides a method of dispensing pharmaceutical preparations to a

patient, wherein a single capsule is filled by a pharmacist with a plurality of active substances, the combination of the active substances and their dosage being as individually prescribed for the patient by his medical practitioner.

Preferably, such capsules should be prepared and packed in an easily available pack for patients locally in community or hospital pharmacies.

Conveniently, the individual active substances may be formulated into standard sized micro-spherical dose forms enabling dispensing of potencies identical to conventionally formulated tablets, with proven bioequivalence when administered in the enveloping capsule.

It is important for a medical practitioner or a pharmacist to be able to ascertain the medication previously taken by a patient.

With this aim in mind, it is proposed in accordance with a second aspect of the invention that the capsules, or their packaging if they are blister packed, be marked with a code that permits the contained active ingredients and their dosage to be determined.

In accordance with a further aspect, the invention provides a device to enable the filling and closure of capsules with drug micro-spheres, which comprises a loading station for receiving a canister containing micro-spheres of an active substances, means for counting micro-spheres drawn from a canister and means for introducing the counted microspheres into a capsule.

It is preferred that the capsules should be shaped externally to provide secure mounting onto the device in a predetermined orientation and that their internal shape be

such as to ensure accurate delivery of micro-spheres under gravity.

Conveniently the capsules may be formed in two parts that seal hermetically against each other to prevent entry of water vapour or to contain a preservative gas introduced into the capsules. Such sealing of the capsules is also advantageous in that it prevents tampering.

To comply with'current EU regulations, the filled capsules may additionally be sealed into an'original pack' for dispensing to patients.

In order to count micro-spheres to be loaded from a supply canister into individual capsules, it is possible to use a reciprocating perforated plate, or an indented wheel, controlled by an indexing stepping mechanism.

For proper identification of the capsules, each capsule or more preferably the blister pack containing several capsules may be suitably encoded, for example by means of a bar code or colour coding. The encoded data may be used to identify the dispensing pharmacy, to identify the contained medications.

It is not essential that the code uniquely identify the contained medications and their dosages. As the dispensing pharmacy is identified, it suffices for the pharmacy to maintain a register giving more details about the medications and conveniently such data could be access directly by medical practitioners and hospitals by using the Internet.

As the capsule codes need not carry individual patient details, confidentiality is preserved.

The range of active substances to be formulated in microspheres is potentially wide, but would be most appropriate where the typical dose ranged from micrograms to tens of milligrams.

The external design of the manufacturers'supply canisters for the microspheres may preferably be of standardised dimensions and mechanisms for sealing/unsealing and encoding so as to ensure secure mounting into the capsule filling device and to allow positive identification of the contents of the canister through a mechanical/electrical/radio/magnetic signalling system adopting a standard code.

The internal design characteristics of the manufacturers'supply canister for the microspheres may be variable to permit adjustment of storage conditions for an adequate shelf life for the individual active substances.

For example, the canisters may be filled with an inert gas, masked against entry of light, or coated to prevent water vapour entry.

The external design of the microsphere supply canisters may suitably incorporate a standardised space for labelling giving visual identification and details of contents.

Conveniently, the capsule filling device may be designed to print labels that give details of the dispensing pharmacy, patient name, active substance, manufacturer, expiry date and manufacturers'product codes. Such labels may be self adhesive and prepared for attachment to the original dispensing strip and to the outside of a cardboard box containing treatment supply for a 28 or 30 day period.

The original dispensing pack containing the individually filled capsules should preferably identify capsules for individual days of the week for ease of

treatment compliance. Such packs may also conform to standardised dimensions and carry protrusions and/or perforations for engagement with the mechanism of an optional additional device for the extraction of the capsules from the original dispensing pack at the patients home.

Two types of extracting device such as described immediately above may be envisaged. The first may be fully automatic, containing original treatment pack for one month's supply of capsules, with ability to present the dose form to the patient at a preset time with audible tone/voice recording/visual alert. The second may be a semi-automatic device for easy removal of the capsule from the original dispensing pack, aiding patients with low sight, reduced manual dexterity or poor memory (prompted by magnifying lens window to view day of the week on the contained original dispensing pack).

The individual components for implementation of the invention may comprise pre-manufactured pharmaceutical capsules which are separated into component halves. The lower-parts may be ore-inserted vertically into plastic strips or wheels which hold twenty eight half capsules arranged around the margin of the strip or wheel. The wheel or strip is capable of precision mounting into the capsulefilling device to allow precise filling of capsules with microspheres. A matching plastic strip or wheel is provided to contain pre-inserted matching top-halves of the capsules.

Batch closure of filled capsules is effected by application of opposing strips or wheels containing capsule upper and lower halves.

The capsule halves may be of different colours (e. g. red, orange, yellow, green, light blue, dark blue, brown, black, white, transparent, and they may have superimposed contrasting colour band (s). In this manner, colour coding

may be achieved to allow the composition of the capsules to be identified. Alphanumeric codes may alternatively or additionally be pre-printed onto one half of capsule (e. g.

10 characters) and such codes may be standardised to enable national identification.

The microsphere container will typically contain sufficient spheres for 28 capsules. Asymmetric shape can be used to ensure standard orientation into the capsule filling device. Labels printed onto the container can be encoded to allow automatic transfer of details of manufacturer, active substance, dose, batch, product licence number and expiry date. The container seal is opened only after insertion into capsule filling device for security against loss of microsphere or contamination of contents.

The capsule filling device should be able to carry plastic strips or wheels containing 28 or 30 capsules and to allow mounting of up to 8 manufacturers'containers of microspheres. The filling device should preferably include microprocessor control for accurate dispensing of appropriate numbers of each type of microsphere into each capsule in turn. The microprocessor of the filling device should preferably be capable of able to interface with a pharmacy computer to allow transfer of prescribing information without re-keying of prescription data to the device, and despatching of securely encoded data to distant secure database via internet connection from the device, via the pharmacy computer. The filling device may also be designed to allow future prescription data entry by barcode read directly off prescription form via the pharmacy computer.

Claims

CLAIMS 1. A method of dispensing pharmaceutical preparations to a patient, wherein a single capsule is filled by a pharmacist with a plurality of active substances, the combination of the active substances and their dosage being as individually prescribed for the patient by his medical practitioner.
2. A method as claimed in claim 1, wherein the individual active substances are formulated into standard sized micro-spherical dose forms.
3. A method as claimed in claim 1 or 2, which further comprises marking the individual capsules or their packaging with a code that permits the contained active ingredients and their dosage to be determined.
4. A device for enabling the filling and closure of capsules with drug microspheres, which device comprises a loading station for receiving a canister containing microspheres of an active substances, means for counting microspheres drawn from a canister and means for introducing the counted micro-spheres into a capsule.
5. A device as claimed in claim 4, wherein the device comprises means for hermetically sealing two parts of each capsule to one another after the capsule has been filled.
6. A device as claimed in claim 5, having means for filling the capsules with an inert gas before the capsules parts are sealed against one another.
7. A device as claimed in any of claims 4 to 6, further comprising means for counting micro-spheres to be loaded from a supply canister into individual capsules.

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8. A device as claimed in claim 7, wherein the counting means includes a reciprocating perforated plate, or an indented wheel, controlled by an indexing stepping mechanism.
9. A device as claimed in any of claims 4 to 8, wherein the loading stations having means for identifying the contents of a canister received thereon from coding on the canister.
10. A filling device as claimed in any one of claims 4 to 9, further comprising means for printing labels that give details of the dispensing pharmacy, patient name, active substance, manufacturer, expiry date and manufacturers' product codes.