Package making – Methods – Forming or partial forming a receptacle and subsequent filling
Patent
1997-06-18
2000-01-04
Silbaugh, Ian H.
Package making
Methods
Forming or partial forming a receptacle and subsequent filling
53560, 53900, 264167, 264175, 264266, 264280, 425363, 424467, A61K 944, B29C 4308
Patent
active
06009690&
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a process for the production of divisible tablets by molding a melt which contains an active ingredient in a calender with counter-rotating molding rolls which have on their surface depressions for receiving and molding the tablet composition (melt calendering).
The production of tablets by calendering a melt containing an active ingredient is disclosed in DE-A 1 766 546 and U.S. Pat. No. 4,880,585. The basis of this process is the embedding of an active ingredient in a melt of a carrier, eg. fatty substances or water-soluble thermoplastic polymers. The melt is produced by melting the mixture of active ingredient, polymer and, where appropriate, other ancillary substances, for example in an extruder, and molding the melt in a downstream molding calender to give tablets, which harden on cooling. The molding calender comprises a pair of counter-rotating molding rolls which have on their surface corresponding engravings (depressions) which correspond to the shape of one half of the required tablet. The tablet molding takes place in the region of contact of the two rolls by combination of the tablet composition in one depression on one roll with that in the opposite depression on the other roll. Calendering of the melt containing an active ingredient as disclosed in U.S. Pat. No. 4,880,585 took place using a pair of molding rolls with identical depressions. In this way each molding roll provides an identically shaped half of the tablet so that the resulting tablets are symmetrical.
It is often desirable for tablets to be divisible in order to be able to alter the dosage without the need to produce individual tablets for each particular dosage. However, the production of divisible tablets by calendering has met with considerable difficulty. Attempts have been made to provide the molding rolls with depressions which afford tablets which are visually identical to the divisible tablets produced by conventional tableting techniques. This has been brought about by leaving, when cutting out the depressions, a small rib, often in the micrometer range, in the middle of the bottom of each depression, which leads to formation of what is called the score (on each half of the tablet, on both sides) in the finished tablets. However, the manufacture of such molding rolls entails a considerable increase in cost. This is because, after the depressions have been cut out, a polishing is necessary to smooth the surface. This is possible in such a case only manually and meets with considerable difficulties because of the ribs present in the depressions.
It is an object of the present invention to provide a process for the production of divisible tablets by melt calendering which can be implemented in a simple and cost-saving manner.
We have found that this object is achieved by combining two molding rolls together, at least one of which has depressions which are separated from one another by at least one bar which extends essentially as far as the surface line.
The present invention therefore relates to a process for the production of divisible tablets by molding a melt containing an active ingredient in a calender with two counter-rotating molding rolls which have depressions for receiving and molding the melt to tablets, wherein at least one molding roll in which the depressions are divided by at least one bar which extends essentially as far as the surface line of the molding roll, and forms a score, is used.
The tablets are formed by combination of the depressions on the first molding roll with the corresponding depressions on the second molding roll. The bar present in the depressions is relatively narrow and leads to formation of the score on molding of the tablets.
In a preferred embodiment there is use of a first molding roll in which the depressions are divided by n bars, and a second molding roll with corresponding depressions divided by n' bars. In this case, n' is in the range from 0 to n-1.
The number n of bars in the depressions on the first roll depends on the number of parts the tab
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Breitenbach Jorg
Fricke Helmut
Maier Werner
Rosenberg Joerg
BASF - Aktiengesellschaft
Lee Dae Young
Silbaugh Ian H.
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