Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Gas produced in situ by chemical reaction
Patent
1984-08-20
1986-09-30
Lovering, Richard D.
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Gas produced in situ by chemical reaction
25218831, 252350, 2523635, 514163, 514474, 514629, 514960, 514961, A61L 904, B01F 312, C06D 510
Patent
active
046146482
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to an improved process for manufacturing effervescent mixtures and tablets containing in particular active principles for pharmaceutical use.
In this domain, positive progress has been made by the techniques described in French Pat. Nos. 71 12175 and 71 35069.
These techniques employ three stages of operation: quantity of demineralized water, then addition of citric acid and possibly of glycocoll (binding agent), all this in a mixer of the kneader type, which starts off the reaction of the bicarbonate on the citric acid; which interrupts the reaction;
The two Patents mentioned above describe with precision the details of the modus operandi for each of the three phases: duration, temperature of the air, humidity content, speed of the air jet, etc., and the man skilled in the art may usefully refer to them.
Although very interesting, this technique presents the drawback of necessitating the transfer of the filler, after step (1), from the mixer to the drier. Consequently, the effervescent reaction triggered off in the mixer cannot be mastered with total precision as its interruption, which occurs in step (2) in the drier, depends on the time for emptying and transferring the filler towards the drier, which time varies from one batch to the following.
This variation in time has a considerable repercussion on the quality of the grain at the end of granulation.
No solution to this problem of industrial working has been found since the invention of the technique, about twelve years ago, despite the obvious interest in solving it and the attempts which have been made to that end.
It has now been discovered, according to the invention, that all of the reactions and operations described hereinabove can be carried out in one and the same multi-function apparatus.
Taking into account the very high precision required in these operations in order to satisfy the very strict quality requirements laid down by the pharmaceutical industry (particularly concerning the homogeneity of the finished granule, and the interruption at a very precise degree of advance of the reaction initiated by the addition of solvent), this was not considered possible.
However, Applicant has achieved this result and, moreover, has also improved the quality of the granules.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be more readily understood on reading the following description with reference to the accompanying drawings, in which:
FIG. 1 shows the apparatus, and in particular the granulator-drier, used for the tests referred to hereinbelow according to one variant embodiment of the invention.
The references in FIG. 1 have the following meanings:
The operation of such an apparatus is obvious and is, moreover, generally known.
FIG. 2 schematically shows the arrangement of apparatus according to another variant of the invention in a production tower.
In FIG. 2, the references have the following meanings:
DESCRIPTION
According to a first variant of the invention (FIG. 1), a granulator-drier operating entirely in fluid bed is used.
Granulator-driers of the type which will be described hereinafter have been known for a long time.
However, it was not thought possible that the turbulence created in such apparatus by the blowing of air could suffice to suitably "imbricate" the particles of the starting reactive materials, which is essential in the technical sector in question, and it was thought, on the contrary, that only a "mechanical" stirring, i.e. of the type obtained by the blades in the mixers used in the prior known technique, could give a valid result. This is why no attempt has ever been made to use the granulator-driers, which are nonetheless well known.
It has now been unexpectedly discovered that these apparatus enable the particles of the starting material used in the technique in question to be correctly imbricated.
It is therefore possible to carry out the three operational steps mentioned above in one and the same apparatus, with the following very important advantages both as regards the qua
REFERENCES:
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patent: 2497057 (1950-02-01), Pape et al.
patent: 2985562 (1961-05-01), Millard et al.
patent: 2999293 (1961-09-01), Taff et al.
patent: 3401216 (1968-09-01), Coletta
patent: 3480185 (1969-11-01), Steinberg et al.
patent: 3773922 (1973-11-01), Gergely
patent: 3903255 (1975-09-01), Gusman et al.
patent: 4267164 (1981-05-01), Yeh et al.
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