Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Sulfur – selenium or tellurium compound
Patent
1998-11-13
1999-11-30
MacMillan, Keith D.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Sulfur, selenium or tellurium compound
A61K 3110
Patent
active
059944110
DESCRIPTION:
BRIEF SUMMARY
The application, 371 of PCT/HU97/00090 (filed on Dec. 30, 1997), has priority of foreign application Hungary P 96 03631, filed on Dec. 30, 1996.
FORMULATED PRODUCT
Subject of the invention is a molecule characterised by the general structure as no. I., where of view, embryonic retardation or discordance.
The application of the formulated product containing calcium dobesilate as an active ingredient in the human therapy from the 1970's has been known in several indication area.
The active constituent is applied in several formulated forms, among which the most important products are the oral products (tablet, capsule) and which are known after their widespread registered name as Doxium manufactured by e.g. the OB Lab. (Switzerland).
The manufacture of the calcium dobesilate (calcium salt of 2,5-dihydroxybenzene sulphonic acid) is discussed in the U.S. Pat. No. 3,509,207 and ES 335945 patents.
Major indication areas and experiences are reviewed as follows.
The examination of 120 patients suffered in venous dilatation (primer and secunder varicosity) were done by Pietrek, G. (Z. Allg. Med. 56./1980/1217-1222) after 3 months long oral Doxium treatment. According to his experience the complaint of the patients decreased (parachroma, oedema, excess weight sensation).
The treatment of patients suffered in chronic venous insufficiency by double-blind examination was reported by Haachen, H. J. and Lorenz, P. (Angiology 1982. July 33 (7) 480-488). As a result of the treatment with Doxium the subjective complaint of the patients significantly decreased and their health improved according to the plethysmographic analysis too.
Patients suffered in the above illnesses were examined by Balmer, A. (Schweiz. Rundscbau fur Med. Praxis, 67 (39) 1978, 1440-1443) before and after the external treatment with Doxivenil gel. This product contains 2% calcium dobesilate and 2% heparinoid (potassium hydrodextran sulphate). Patients tolerated the treatment very good, and the health condition of 80-87% of them turned to favourable.
Three months long treatment of patients for diagnosed retinopathy deabetica with oral Doxium was published Barras, J. P. and Graf, C (VASA/1980/9(2)161-164). According to three different analytical methods at the end of their experiment the viscosity of both the plasma and the whole blood reduced. The relative viscosity and the hematocrit value remained unchanged.
The capillary permeability of diabetic patients were examined by Sevin, R. and Cuendet, J. F. (Ophtalmologica 162:33-40/1971/33-40). Retinopathic patients were divided into the following four groups:
According to the results of the fluorescein angiographic analysis the oral dosage of Doxium has a favourable effect on the pathological permeability of the capillaries, and the capillary resistance values.
Treatment of pile haemorrhage with Doxiproct suppository (containing 250 mg calcium dobesilate and 40 mg lidocain active constituent) was published by Berson, I. (Schweizerische Rundschau fur Med. Praxis (1975.03.11./64 (10) 299-301). As a result of dosing two times per day for two weeks, improvement was detected 87% of the cases.
Summarising the literature data it can be concluded, that the known indications for the oral application of the calcium dobesilate are the followings: microangiopathy; particularly retinopathy deabetica; chronic venous insufficiency; primer varicosity; pregnancy varicosity; leg ulcer; night sural spasm; ankle oedema. On the basis of the data being available at present, it is applicable as an adjuvant in the following cases: external thrombophlebitis; postthrombotic syndrome; oedema; stasis dermatosis; piles complaint.
According to the literature data relating to the way of action, the calcium dobesilate effects via the regulation of the pathological capillaric wall functions (increased permeability and reduced resistancy). It inhibits the decomposition of the collagen fibres, reduces the hyperviscosity of both the plasma and the blood. Indirectly it inhibits the lymph flow, and as a consequence of this reduces the oedem
REFERENCES:
patent: 3509207 (1970-04-01), Esteve-Subirana
Embase Abstract No. 97179584.
Ghiglione et al., Treatment of nonproliferative diabetic retinopathy with a peptide fraction, Drug investigation,(1992) 4/1 pp. (1-6) May 1992.
Agni Zsolt
Bartok Gabor
Bedo Tibor
Pok Tibor
Vojcek Laszlo
Biogal Gyogyszergyar RT
Kim Vickie
MacMillan Keith D.
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