Use of sodium 2-mercaptoethanesulfonate in surgery

Details Use of sodium 2-mercaptoethanesulfonate in surgery Use of sodium 2-mercaptoethanesulfonate in surgery

1999-06-09

2000-11-07

Jarvis, William R. A.

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Sulfur, selenium or tellurium compound

A61K 3110

Patent

active

061437972

DESCRIPTION:

BRIEF SUMMARY
The present invention refers to topical pharmaceutical formulations containing sodium 2-mercaptoethanesulfonate (MESNA), the use of MESNA for the preparation of pharmaceutical formulations intended to be used in surgical procedures that involve the dissection of tissues and the use of MESNA in said surgical procedures.
One of the fundamental principles of surgery performed on all parts of the human body consists in detaching the various pathological tissues from the healthy tissues with which they have formed adherences. Furthermore, in most cases during the surgical approaches, even healthy tissues need to be detached from each other in order to penetrate deep through the cutaneous layers.
At present, such detachment is performed only with mechanical instruments separating the adherent surfaces using "dissectors", stripping therefore adherences between the two surfaces or cutting them with the bisturi or scissors.
The detachment of tissues according to the present method can be quite tedious and is often responsible for long surgical operations. An important technical progress in this field would be to facilitate the detachment of tissues, thereby reducing operation duration, the medical cost of such operations, as well as health risks for the patient.
Sodium 2-mercaptoethanesulfonate (hereinafter referred to as MESNA), is included in a class of thiolic drugs which produce mucolysis by breaking the disulfur bridges of the polipeptide chains of mucus.
Up to now MESNA was present in the market as topical aerosol, nasal spray and intravenous formulations. The registered indications include the treatment of pathologies of the respiratory system such as chronic bronchitis, bronchitis with asthma, asthma, bronchoconstriction, emphysema, bronchiectasis and mucoviscidosis, rhinitis and chronic pharyngolaringitis.
During the post operative phase, MESNA is moreover used together with respiratory physiotherapy, to facilitate expectoration and as coadjuvant in the prevention of pulmonary complications due to obstructive bronchial phenomena. It is also useful in pulmonary atelectasies due to bronchial occlusion.
Moreover in the oncological field MESNA is used to prevent toxic lesions of the urinary tract by antineoplastic agents such as oxazaphosphorines/cyclo-phosphamide, iphosphamide).
We have now surprisingly found that MESNA facilitates the dissection of tissues during surgery when applied in the form of a topical formulation on the tissues to be dissected.
Thus, the present invention provides topical formulations, preferably sterile solutions or powders, which can be directly applied during surgical procedure on the tissues in order to facilitate their dissection.
More specifically, such formulations may be in the form of sterile solutions at concentrations of MESNA ranging from 1 to 50% by weight, preferably 10-20% by weight, or dispersive powders. The dosage of the formulations is not limited by side-effects due to the optimal tolerability of MESNA when it is applied directly to tissues.
The formulations of the invention can be used in any surgical procedure where the dissection of the various tissue layers is necessary.
The invention is particularly useful in E.N.T. (Ears, Nose and Throat) surgery during which frequently difficult cases can be encountered.
One of these surgical indication is the removal of cholesteatoma.
The topical formulations containing MESNA facilitate removal of the "glue" in otitis media with effusion and facilitate the removal of cholesteatoma debris pre, intra and post operatively (in the case of recurrent cholesteatoma). The topical formulations of the invention allow the chemically assisted dissection (CADISS) of the matrix of the cholesteatoma in the mastoid, epitympanum and posterior mesotympanum. Moreover, they facilitate the dissection of the matrix from the oval and round windows, from the bones of the inner ear and particularly from the stapes and from the facial nerve. During second stage procedures in tympanoplasty, they allow to rapidly remove the connectival covering which

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