Polymethylsiloxane polyhydrate (PMSPH), or methylsilicic acid hydrogel (brand name Enterosgel), is an enterosorbent used for binding and removing various toxic substances, infectious agents and metabolites from the gastrointestinal tract. It is available in the form of a white or almost white homogeneous pasty mass. It is odorless and tasteless.
History This product was synthesized in the late 1970s to early 1980s in the USSR by I. B. Slinyakova and I. М. Samodumova of L. B. Pisarzhevskiy Institute of Physical Chemistry (Kyiv), where the theoretical foundations for the formation of the porous structure of organosilicon adsorbents with an adjustable porous structure and a pre-defined chemical nature of the surface were established; there were also efforts to synthesize organosilicon adsorbents, namely porous polymers polyorganosiloxanes. Industrial production of the preparation began in early 1991. In 1994, a medicinal drug with methylsilicic acid hydrogel as the active ingredient, marketed under the brand name Enterosgel, was registered in Ukraine and Russia, and active sales of the new product began. Currently, the product is already available in 40 countries. The study of the use of the preparation was conducted in cooperation with the Medical Service of Krasnoznamennyi Kiev Military District (Medical Service Colonel Professor F. G. Novikov, Medical Service Colonel N. P. Bezlyuda). Since, many clinical trials investigating the preparation have been conducted by Ukrainian and Russian companies in the CIS. A large-scale study of its effect was conducted in the United Kingdom between 2019 and 2022. It established a proven base of effectiveness of the preparation in the treatment of irritable bowel syndrome with diarrhea, help in relieving bloating, abdominal pain and urgency. The preparation is registered in Russia and the CIS countries as a medicinal drug, and in the countries of the European Union, Serbia, New Zealand, Africa as a medical device, since the product is not absorbed into the bloodstream and acts as an adsorbent only in the gastrointestinal tract, it fits the relevant definition according to the Classification of the European Commission. The medical device Enterosgel is produced in a factory in Jeseník, Czech Republic, from where it is exported to all countries of the world, except Russia and the CIS countries. This region supplies production in Russia, where a factory is situated in the city of Dankov.
Structure PMSPH is a polymeric gelatinous organosilicon compound. The gel is dispersed in water to a particle size of no more than 300 microns. The preparation is a suspension which is taken orally.
Microstructure Electron microscopic studies have shown that its gel-forming matrix has a globular structure and consists of an ensemble of fused globules. These globules, bound together by siloxane bonds, form pores. The pores are the spaces between the globules. They are filled with water. Pore size is restricted. The presence of methyl groups on the surface ensures its hydrophobic properties. PMSPH particles tend to form a continuous network in a suspension to reduce the interaction of hydrophobic SiCH3 with water. These particles can be viewed as two-dimensional sheets rather than three-dimensional solid particles. Aqueous suspensions of polymethylsiloxane polyhydrate are characterized by high viscosity.
Mechanism of action The physical and chemical characteristics of PMSPH define its absorptive and protective properties:
The solid porous structure of the gel-forming matrix determines absorption capacity by the molecular adsorption mechanism and allows predominantly adsorbing medium molecular weight toxic substances and metabolites (e.g. bilirubin and products of protein breakdown). Due to its gel-like consistency: it absorbs high-molecular-weight toxic substances by the mechanism of co-precipitation in the gel (e.g. bacterial toxins); it shows protective properties—its elastic gel-like particles form a layer on the surface of mucous membranes. This layer protects mucous membranes from various damaging factors, and its protective properties are manifested universally—in the intestine, and on the surface of the mucous membranes of other organs. It absorbs toxic substances produced in the gastrointestinal tract, as well as toxic substances entering the gastrointestinal tract from the environment (e.g., ethyl alcohol). It also prevents reabsorption of toxic substances and metabolites excreted into the intestinal lumen from the blood, as well as getting into the intestine with bile. In an in vitro experiment, it reduced the production of staphylococcal enterotoxin and inhibited the growth of Staphylococcus aureus. It reduced malonic dialdehyde formation and increased integral antiradical activity in toxic liver damage in vivo. Due to adsorption in the gastrointestinal tract, it helps reduce blood sugar and glycated hemoglobin levels, eliminate lipid distress syndrome, including diabetic dyslipidemia, improves energy processes in liver tissues in experimental diabetes. PMSPH firmly binds and excretes pathogenic bacteria and rotaviruses.
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