FR2507079A1 - - Google Patents

Abstract

THE OBJECT OF THE INVENTION IS A PROCESS FOR OBTAINING AN ANTITETANIC VACCINE ADMINISTRABLE BY SUBLINGUAL ROUTE. THIS PROCESS CONSISTS OF SUCCESSIVELY: A.PURIFYING THE TETANIC TOXOID TO ACT AS A VACCINE; AND B. REBUILD THE PURIFIED TETANIUM TOXOID, WITH BIDISTILATED APYROGEN WATER, TO MAINTAIN AND CONTAIN ALL OF ITS SUBLINGUAL ACTIVE IMMUNIZING ACTIVITY. APPLICATION: ANTITETANIC VACCINATION AVOIDING THE DISADVANTAGES AND RISKS OF PARENTERAL ADMINISTRATION.

Description

The present invention relates to a novel process

  for the production of tetanus toxoid vaccine, a vaccine with

  properties and properties that make it suitable for the administration

  new way, more specifically the sublingual route.

  In particular, the invention relates to a novel technique for obtaining tetanus toxoid vaccine by means of a special treatment of tetanus toxoid in order to obtain

  to act, that is, to be absorbable, by

  This special treatment, which will be described in detail below, consists of a method of copulation of

tetanus toxoid.

  Various researches worldwide are carried out under the auspices of many international organizations, among

  including the Institut Pasteur, with a view to obtaining new

  the routes of administration of the tetanus toxoid vaccine, for the purpose of eliminating the parenteral route, used exclusively up to now, which route, as we know, has adverse effects, such as: hyper-allergic reactions, necrosis, and

neuroparalytic syndromes.

  For these reasons, research has been carried out on laboratory animals with tetanus toxoid, after

  purification, stabilization, filtration and lyophilization

  lisation; it has been surprisingly proven that

  groups of animals that said treated toxoid was absorbed

  sublingually and that immunizing antibody levels

  periours to 0.01 antitoxic units were obtained.

  Moreover, under conditions of guaranteed

  atoxicity, studies of the new vaccination method

  antitetanic nation, were subsequently performed sublingually on the human person the results obtained were

  in vaccinated individuals, a percentage of

  77.5% at the same time as it was highlighted.

  a complete absence of harmful side reactions

  the number of people examined was 1,074.

  In the light of the above, we can say that

  this discovery provided a new method of administering

  tion of the classical tetanus toxoid, after prior treatment of the latter, which excludes the disadvantages and the dangers inherent to any injection, such as the reaction of hyperergy, necrosis

  and neuroparalytic syndromes, among other adverse effects.

  Until the present invention, the vaccine

  tane only has been administered only by way of

  lateral approach, which can lead in parallel to inde-

  described in the previous paragraph.

  As advantages provided by this invention, by

  compared to the prior art, it can be emphasized

  the following: 1) Less harmful side effects, as well as avoiding the dangers of an injection,

  such as: hepatitis and neurological symptoms, among others.

  2) Elimination of local problems as a consequence

  this of the wording itself; in this respect, it is necessary to indicate

  that the Institut Pasteur has established that "the aluminum salts frequently used in tetanus toxoid compositions,

  promote the appearance of cancer in mice ".

  3) Use of a route of administration namely, the sublingual route, which is better accepted by the public in the

Sanitary campaigns.

  The present invention relates to a new

  assigned for the production of a tetanus toxoid vaccine capable of being administered by the sublingual route, which process consists essentially of subjecting the tetanus toxoid to a special treatment or copulation method, so that it can act,

  that is, it is absorbable, sublingually.

  The tetanus toxoid used as

  part of the process of the invention, is that which is homo-

  for biological products by the World Health Organization; it must be subjected to all the reactions described for this toxic in the ratio No. 30 of the O M S. In particular, in the process of the invention,

  can use tetanus toxoid of 25 l f (Flocculating Threshold

  approximately) per drop, equivalent to about 500 l f.

  The process of discovery is characterized by the following steps or phases that must be performed: a) purifying the toxoid of previously cited characteristics for the purpose of obtaining a purified and active tetanus toxoid for vaccines; and b) rebuild the purified tetanus toxoid with

  pyrogen-free double-distilled water treated with preservatives

  appropriate substances which do not alter the toxoid or the container containing

  for the toxoid to retain and contain all its activity

  immunizing active sublingually.

  As a purification method to be employed in the first step of the process of the invention, it is possible to employ

  physical methods, such as filtration, freeze-drying,

tion and others like it.

  Tetanus toxoid through the process of discovering

  green was subjected to the following characterization tests 1) identification test 2) sterility test 3) activity test; 4) test of the content of adjuvant substances) innocuousness test; 6) agent content test; and 7) determination of p H. All of these tests are described in Report No. 30

  of the World Health Organization.

  The procedure used to verify the activity of the tetanus toxoid vaccine obtained according to the invention is carried out on animals, including rabbits and guinea pigs by administering to a group of 20 rabbits or guinea pigs, sublingually, a drop of the vaccine of 1 g per drop (tetanus toxoid) treated according to the method of the invention After 18 to 21 days, a drop is deposited again sublingually and in the week it is checked, by hemoagglutination, if the vaccination was effective

  in 80% of the animals, levels of circulating antitoxin were

  more than 0.01 Units Antitoxin Internationa-

  this makes it possible to obtain immunity in 80% of the treated animals

  for infection produced by Clostridium Tetani.

  By revaccinating these same animals 6 months later,

  an immunizing antibody level greater than 0.01 Uniform

  antitoxic in 90% of the immunized animals.

  These percentages are similar to those obtained by the inoculation of parenteral and non-parenteral toxoids, the only route used to date for the prevention of tetanus,

  and at the same time sublingual elimination of inde-

  sirables of the parenteral route mentioned previously.

  Likewise, as mentioned above, a group of 1,074 people were subjected to an exam or practical test

  of the vaccine obtained according to the invention, administered sublingually

  the; a percentage of immunity of the order of 77.5% was obtained

in vaccinated persons.

  Since the nature of the invention and the manner in which it has been practically implemented have been sufficiently described, it should be pointed out that the above-mentioned provisions are susceptible to modifications of detail to the extent that they do not alter its fundamental principle.

Claims (4)

  1 Process for the production of tetanus vaccine   administered sublingually, characterized by the following steps:   (a) purify tetanus toxoid to act as a vaccine; and b) rebuild purified tetanus toxoid, with pyrogen-free bidistilled water, for the toxoid to retain and   contains all its active immunizing activity by sublin-   Guale. Process according to Claim 1, characterized by   the fact that, as a starting toxoid, the tetanus toxoid is used   25 l f (flocculant limits) approximately   te, equivalent to some 500 l f per cm 3.   Process according to any one of the claims   1 and 2, characterized by the fact that as a purification technique   In step (a), a physical method is used, in particular   bind filtration and lyophilization.   Process according to any one of the claims   I to 3, characterized in that the bidistilled water used in step (b) contains preservatives which do not alter   the toxoid or container containing.