US3473490A - Producing chronoactive pharmaceutical granules - Google Patents

Producing chronoactive pharmaceutical granules Download PDF

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Publication number
US3473490A
US3473490A US609023A US3473490DA US3473490A US 3473490 A US3473490 A US 3473490A US 609023 A US609023 A US 609023A US 3473490D A US3473490D A US 3473490DA US 3473490 A US3473490 A US 3473490A
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Prior art keywords
chronoactive
tablets
dies
granules
producing
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US609023A
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English (en)
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Camillo Corvi-Mora
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Individual
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Individual
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets

Definitions

  • the so-called sweetbread or granule nucleus is obtained by empiric methods carried out in said coating pan, or by granulating devices provided with selecting sieves providing granulated compounds formed of equally sized particles which are then placed in the pan for the delaying re-treatment, as previously mentioned.
  • the known method allows very low yields as to the amounts of active materials being used, owing to the numerous passages and hence to the possible alteration of the most transient active materials due to process length and necessity of particularly minute and repeated controls; moreover, it is the feature of the methods still in use and from which the present process particularly differs to require a high weighing ratio of the excipients to the active materials and thus the inability of efiecting high dosages of active materials: only in some cases concentrations of 50% could be experimentally obtained. Generally, concentrations of 20-30% can be considered as good concentrations.
  • This novel method for producing chronoactive granules differs from the methods heretofore used in that powders of a high active material concentration (up to 95 and more) are prepared, while the excipients amount to 5% or less of the total mixture, small tablets being prepared from such powders with a diameter of about l2 mm.
  • This novel method clearly differs from all the other present methods in using a multiple tablet making ma- 3,473,4W Patented Get. 21, 1969 chine provided with small dies, while the other methods make use of long and delicate manual pan processes prior to coating.
  • Granules or nuclei obtained according to the present method are of a larger size than those obtained by known manual methods, while chronoactive granules being produced do not differ as to therapeutic effect; the granules obtained by the present method firstly show the advantage of having very high concentrations of active materials (up to and more) which could not be absolutely obtained by the other methods in which, due to manual working, it is necessary to resort to a high weighing ratio of the active materials to the excipients associated therewith.
  • the conventional technique for preparing chronoactive granules requires the interleaving of films of active and supporting materials.
  • Each layer of active material being added by panning for granule forming must have an underlying layer of sugar syrup: in turn, the active material has to be absorbed on levilite, talc, or another excipient. Accordingly, the granule will be mostly (at least 50% in weight) and necessarily formed of excipients. This avoids high concentrations of active materials to be obtained with resulting disadvantages of a technical and practical character:
  • sweetbread already containing an active material instead of using a sugar sweetbread (initial nucleus of the granule) will not alter the terms of the problem, since the highly reduced size of said sweetbread does not allow an active material addition in such amounts as to substantially modify the weighing ratio of the excipients to the active material.
  • the high pressures of the tablet making machine on the granulated powders of the active materials will allow compact and stable tablets to be obtained, said tablets being almost entirely formed of active materials.
  • the working period is reduced to about one-tenth, with a minimum possible alteration of the most transient active materials since the manufacturing process is greatl simplified and shortened;
  • FIGURE 1 an explanatory diagram of the machine
  • FIGURE 2 the enlarged partial cross-section of the end of a die and bottom-die thereof.
  • FIGURE 1 shows a bank of minute dies or punches 10 parallelly mounted on a single piston 11,
  • the vessel 12 containing the powder mixture (about 95% active and about 5% excipient) is arranged and at the bottom the bank of bottom-dies 13 coaxially mounted and facing the dies on a single backor end-piston 14, which is common to all the bottom-dies.
  • Both the banks of dies 10 and bottom-dies 13 may be movable, or only one of them may be movable.
  • Each top die and bottom-die terminates in a small hemispherical cup 16 or 17 so as to form substantially in the form of about 1 mm. After being introduced into a pan, coating and manufacturing thereof as gelatine capsules are conventionally carried out.
  • the main active materials intended to make up the composition of the small tablets are first processed by mechanical procedures in order to convert the same in an as far as possible uniform granulated form to facilitate the compression of the powders which will be accomplished in second step in the tablet making machine.
  • the proportion of active materials of the granulated product may reach 95% and more, while the remainder is formed of excipient materials and lubricants.
  • the proportion of active materials of small tablets produced by means of the multiple tablet making machine may reach 95 and more, which could never be obtained by any system at present used for preparing similar pharmaceutical forms having the same purpose.
  • the granulated product is compressed in the desired form and size within said machine, the piston 11 of which carrying the bank of dies 10 is driven by a connecting rod and cam (not shown). Piston 11 falls back in vessel 12, wherein a mechanically moving hopper of a conventional type (not shown) stores the desired amount of granulated product.
  • Top punches 10 mounted on piston 11 fall back in apertures of bed die bottom 15, which apertures form die cavities. From the bottom a back or end-piston 14 with a bank of bottom-dies 13 ascends with the same speed as and in synchronism with the top dies 10, thus allowing a plurality of small tablets having a desired and predetermined diameter and thickness to be obtained at each stroke.
  • the dies are provided by special, high strength steel punches having a diameter of 2 mm. and being slightly hollowed out at the end. The concavity of the top dies and bottom-dies will allow substantially spherical small tablets to be obtained.
  • Precompressed powder is driven into the die cavities by the punches moving through a reservoir. In a uniform direction of flow, the tablets are removed from the lower ends of the cavities. Therefore, the punches may be driven through a confined mass of powder and the powder precompressed as it is being driven into the cavities. This precompression is in turn responsible for the ability to manufacture tablets with such high concentration of pharmaceutically active ingredients.
  • the small tablets being produced are then transferred to a copper pan for a short period of time and are agitated in the pan, the friction between the pan and the tablets and between the tablets themselves enhances the spherical form thereof and rendering the groups of tablets more fiowable and more readily measurable.
  • the method for producing chronoactive tablets com prising: confining a mass of loose powder within a stationary vessel having a vertical confining wall surrounding the mass of loose powder and having a bottom supporting said mass of loose powder on its upper face and provided with vertically disposed apertures forming die cavities underlying said powder mass and extending through said bottom from its top face to lower ends terminating in its lower face, moving a plurality of first punches having concave end faces through the confined mass of powder into the die cavities, thereby filling and compressing the powder in the die cavities, while concurrently moving a plurality of second punches having concave end faces into the die cavities from their lower ends, thereby compressing powder in the die cavities to form compressed tablets.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
US609023A 1966-01-17 1967-01-13 Producing chronoactive pharmaceutical granules Expired - Lifetime US3473490A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT66966 1966-01-17

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US3473490A true US3473490A (en) 1969-10-21

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US609023A Expired - Lifetime US3473490A (en) 1966-01-17 1967-01-13 Producing chronoactive pharmaceutical granules

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US (1) US3473490A (en(2012))
BE (1) BE692660A (en(2012))
DE (1) DE1617595A1 (en(2012))
FR (1) FR1570421A (en(2012))
GB (1) GB1147245A (en(2012))
NL (1) NL6700749A (en(2012))

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4797287A (en) * 1984-06-19 1989-01-10 Basf Aktiengesellschaft Cylindrical microtablets
US20060222705A1 (en) * 2005-03-31 2006-10-05 Flanner Henry H Pharmaceutical tablet and apparatus and method for making
US20120319328A1 (en) * 2010-03-05 2012-12-20 Taisho Pharmaceutical Co., Ltd. Tablet manufacturing method

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1246382B (it) * 1990-04-17 1994-11-18 Eurand Int Metodo per la cessione mirata e controllata di farmaci nell'intestino e particolarmente nel colon
CN110884196A (zh) * 2019-10-28 2020-03-17 广东新乐食品有限公司 一种双层压片糖自动压片成型装置及成型方法

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US523430A (en) * 1894-07-24 Press f or plastic materials
US613758A (en) * 1898-11-08 Pill-making machine
US2410110A (en) * 1943-01-14 1946-10-29 Brewer & Company Inc Method of making tablets
US2735380A (en) * 1956-02-21 Means for tableting sugar
US3118183A (en) * 1961-05-05 1964-01-21 Procter & Gamble Rotary tablet press having means to rotate the plungers
US3175521A (en) * 1961-02-23 1965-03-30 Schering Corp Apparatus for punching miniature tablets
US3332367A (en) * 1965-07-15 1967-07-25 Upjohn Co Apparatus for making tablets
US3390648A (en) * 1963-09-19 1968-07-02 Wander Ag Dr A Procedure for coating particles

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US523430A (en) * 1894-07-24 Press f or plastic materials
US613758A (en) * 1898-11-08 Pill-making machine
US2735380A (en) * 1956-02-21 Means for tableting sugar
US2410110A (en) * 1943-01-14 1946-10-29 Brewer & Company Inc Method of making tablets
US3175521A (en) * 1961-02-23 1965-03-30 Schering Corp Apparatus for punching miniature tablets
US3118183A (en) * 1961-05-05 1964-01-21 Procter & Gamble Rotary tablet press having means to rotate the plungers
US3390648A (en) * 1963-09-19 1968-07-02 Wander Ag Dr A Procedure for coating particles
US3332367A (en) * 1965-07-15 1967-07-25 Upjohn Co Apparatus for making tablets

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4797287A (en) * 1984-06-19 1989-01-10 Basf Aktiengesellschaft Cylindrical microtablets
US4828843A (en) * 1984-06-19 1989-05-09 Basf Aktiengesellschaft Cylindrical microtablets
US20060222705A1 (en) * 2005-03-31 2006-10-05 Flanner Henry H Pharmaceutical tablet and apparatus and method for making
US20120319328A1 (en) * 2010-03-05 2012-12-20 Taisho Pharmaceutical Co., Ltd. Tablet manufacturing method

Also Published As

Publication number Publication date
BE692660A (en(2012)) 1967-07-03
GB1147245A (en) 1969-04-02
DE1617595A1 (de) 1971-04-01
NL6700749A (en(2012)) 1967-07-18
FR1570421A (en(2012)) 1969-06-13

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