MEDICAMENTS ENCAPSULES INVIOLABLES

TAMPER PROOF ENCAPSULATED MEDICAMENTS

Abrégé anglais

AEIP-8840
ABSTRACT
A tamper-proof capsule dosage form for pharmaceuticals having a
medicinal containing caplet adhesively bonded to the inner end surfaces of the
capsule such that upon tampering the capsule dosage form will be destroyed or
rendered non-reusable.

Revendications

AHP-8840
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THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A tamper-proof capsule dosage form containing a pharmaceutical
medicament for oral administration comprising:
a) an elongated essentially round hard gelatin capsule made in two
sections slip-fit joinable;
b) a solid caplet containing a medicament susbtance shaped and sized
closely to fit within the assembled capsule; and
c) a pharmaceutically acceptable adhesive situated between each caplet
end and the adjacent inner surface of the capsule.

Description

A~P-8840
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TAMPER PROOF ENCAPSULATED MEDICAM~NTS
Background Of The Invention
This invention related to a tamperproof capsule dosage form for
pharmaceutical preparations and more part;cularly to a hard gelatin eapsule
dosage form which will be destroyed if opened so that extraneous substances
cannot be inserted in the opened capsule and the capsule then re-closed.
The art is replete with systems for loclcing capsules containing
pharmaceutical preparations for oral administration. For example, sound waves
have been used to lock together the two pieces of hard gelatin shell after the
medicament has been enclosed within the capsule formed from the shells. In
another system, the larger half of the two-piece capsule fits almost completely
over the smaller half. In still another system, a gelatin band is applied to thefilled capsule and fused to hold the two capsule pieces together. Such systems
have been found to be lacking in adequate protection, however, since one or
several capsules can be opened and the components used to encapsulate an
: extraneous substance in capsule components closely resembling the original
medication.
mmar~ Of The ~vention
This invention comprises a tamper-proof capsule dosage form
containing a pharmaceutical medicament for oral administration which will be
destroyed ii opened prior to administrQtion. The temper-prooi oapsule dosege
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AHP-8840
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form comprises three basic components including a hard gelatin capsule, a
pharmaceutical medicament in caplet, i.e. elongated tablet shape, and an edible
adhesive, which components, when assembled hold each end of the caplet
adhesively bonded to the adjacent inside surface of the capsule.
Detailed Description Of lhe ~rention
The three basic components of the tamper-proof capsule dosage form of
the invention comprise:
` a) a hard gelatin capsule, well known in the art, such is marketed by
R.P. Seherer Corporation of Troy, New York, made in two pieces in whieh the
medicament, usually in powder or particlllate form, is placed in a first piece and
the other piece is then slip-fitted over and joined to the first piece;
b) a medicinal caplet for oral administration shaped and sized closely
to fit within the assembled capsule; and
;
` c) a pharmaceutically acceptable edible adhesive, the adhesive
bonding each end portion of the caplet to the adjacent inside surface of the
- capsule.
The hard gelatin capsule can be any size from 4 to 000 and preferably it
` should be a clear gelatin so the user can see the caplet inside and also extraneous
`` material, if any.
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A~IP-8840
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The caplet can contain any of the many medicinals presently
marketed over-the-counter or on a prescription basis such as aspirin,
acetaminophen and ibuprofen.
The edible adhesive can be a pharmaceutically acceptable water or
organic solvent soluble adhesive including a protein adhesive such as zein or
casein, a silieone adhesive, a plastic adhesive such as an acrylic polymer, shellac
or a cellulose. Also the adhesive can be a heat-sealable or an ultrasound-
sealable adhesive well known to the art.
The invention will now be described with reference to the
accompanying drawings whereino
; Figure 1 is an exploded view of the tamper-proof encapsulated dosage
form of the invention:
,
Figure 2 is a view of the assembled tamper-proof encapsulated
dosage form of the invention.
Figure 3 is a cross-sectional view along line 3-3, i.e. the elongated
axis of the tamper-proof encapsulated dosage Iorm of the invention; and
;~ Figure 4 is a cross-sectional view along line 4-4, i.e. around the
~. circumference of the encapsulated dosage form of the invention.
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A~{P-8840
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Turning now to ~igures 1 through ~, the caplet 1 is sized closely to fit
into the capsule designated by its two components 2 and 3. The caplet mold can
be designed to provide sufficient tolerance sueh that there is sufficient space at
each end 4 and 5 of the caplet 1 and between the inside surfaces 6 and 7 of the
capsule ends 2 and 3 to receive a drop or two of adhesive designated 8 and 9
respectively.
The tamper-proof dosage form is assembled by placing the adhesive
on each end of the caplet or on the inner end surfaces of the capsule sections,
inserting the caplet into the section of the capsule smaller in diameter, then
slipping the section of the capsule larger in diameter over the exposed end of the
caplet and slip-fitting the two sections together to form the capsule.
.
- Any moisture or solvent in the adhesive will pass through the capsule
wall since the gelatin acts as a semi-permeable membrane. If too much moisture
is present in the adhesive, the capsule may become deformed, and hence it is
preferable to use low moisture content adhesives. Gentle warming of the filled
capsules will accelerate the drying of the adhesive.

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