Mannitol is the “highlight” in the composition of injectable preparations based on hyaluronic acid

Contour plastic surgery with the use of various injectable preparations is becoming very popular today, since the substances included in corrective fillers have an excellent, stable effect, and the result obtained is often quite comparable to plastic surgery.

Not long ago, readers of estet-portal.com learned about the features of collagen stimulation using Delice Hydroxy fillers, which were described by Andrey Danilyuk, an aesthetic surgeon, a specialist in regenerative medicine, and a certified OnCosmetics trainer in invasive techniques in aesthetic medicine. Today we offer a new doctor’s material dedicated to hyaluronic acid fillers.

Pharmacodynamics and pharmacokinetics

Mannitol - what is it?

Mannitol is an osmotic diuretic.

Pharmacodynamics

By increasing the osmotic pressure of plasma and enhancing filtration without tubular reabsorption , it promotes fluid retention in the tubules and an increase in the amount of urine. osmolarity increases, causing fluid to leak out of the tissues into the vascular bed. This leads to a pronounced diuretic effect, in which a large volume of osmotically free fluid, chlorine and sodium is excreted, without significant loss of potassium . Causes an increase in the amount of circulating blood.

Pharmacokinetics

In the liver, Mannitol undergoes minor metabolism to form glycogen . During excretion tubular reabsorption ; the process is controlled by glomerular filtration . The half-life is approximately 100 minutes. Excreted by the kidneys.

Bellarti Hydrate with Mannitol

Bellarti Hydrate is intended for biorevitalization procedures of the face, neck, and décolleté. Mainly using papular and micropapular techniques. Due to the presence of mannitol in the composition, the drug has a lymphatic drainage function and can be used for swelling in the periorbital zone, as well as in the face area with deformation-edematous morphotype in order to reduce tissue pastiness.

Bellarti Hydrate is characterized by a positive effect in the form of lightening the area of ​​“dark circles” under the eyes due to impaired microcirculation.

Initially, mannitol is a drug related to osmotic diuretics, which has diuretic properties. Widely used in clinical practice, in particular in vascular surgery and cardiology. In cosmetology, a number of other valuable properties of mannitol are noted: it has pronounced antioxidant properties and fights reactive oxygen species - free radicals. Another positive effect of mannitol is the reduction in the rate of degradation of hyaluronic acid through hyaluronidases, which significantly prolongs the presence of the drug in tissues.

Indications for use Mannitol

The drug has the following indications for use:

• oliguria in acute renal failure glomerular filtration );
• cerebral edema ; status epilepticus ; intracranial or intraocular hypertension , exacerbation of glaucoma ;
• acute liver failure;
• post-transfusion complications after transfusion of incompatible blood;
• poisoning with salicylates, barbiturates, lithium preparations, bromides; forced diuresis in case of poisoning with other substances;
• to prevent hemoglobinemia and hemolysis during resection of the prostate using the transurethral method, during bypass surgery on the pulmonary-cardiac system, during procedures involving extracorporeal circulation .

Why is the concentration 0.49%?

At the stage of development of the Bellarti line of biorevitalizants, experiments were conducted to select the optimal concentrations of mannitol and glycerol. For this purpose, a study was conducted on the introduction of polyhydric alcohols in different concentrations from 0.4% to 2.0%. Next, the samples were subjected to thermal sterilization and stress testing (peroxide decomposition). Based on the results of the experiment, it was found that a concentration of 0.49% is optimal for both glycerol and mannitol, i.e., it was at this concentration that the best effect of stabilizing HA was observed, associated with a minimal decrease in the viscosity of the drug compared to the samples free of glycerol and mannitol. Therefore, administering both mannitol and glycerol in concentrations above 0.49% does not make sense.

Thus, in addition to the fact that mannitol is a powerful antioxidant, it, along with glycerol, is also a thermal stabilizer for HA, i.e., it retains the properties of the drug during storage, protects HA from the depolymerization reaction during temperature sterilization, minimally affecting the rheological properties.

Instructions for use of Mannitol (Method and dosage)

Instructions for use of Mannitol indicate that this drug is administered intravenously (slow drip or jet method). The preventive dosage is 500 mg per kilogram of weight, the therapeutic dosage is 1.5 g per kilogram of weight. The highest daily dose is 140-180 g.

For interventions with extracorporeal circulation, 20-40 g of the drug is administered immediately before the intervention.

Patients with oliguria are first administered intravenously 200 mg per kg of body weight over 5 minutes. If within 3 hours after this there is no increase in diuresis to 30-45 ml/g, then administration of Mannitol should be abstained in the future.

Mannitol

100 ml in glass bottles with a capacity of 100, 200 ml in glass bottles with a capacity of 250 ml, 400 ml in glass bottles with a capacity of 450 ml, sealed with rubber stoppers and crimped with aluminum caps.

Labels made of label or writing paper or other paper of a quality not lower than specified are glued onto the bottles.

For sale through the pharmacy chain, each bottle, along with instructions for medical use, is placed in a cardboard pack for consumer packaging of brands A and B.

36 packs of 100 ml bottles or 28 packs of 200 ml bottles or 15 packs of 400 ml bottles are placed in a consumer packaging box or corrugated cardboard box.

For hospitals: 36 bottles of 100 ml or 28 bottles of 200 ml or 15 bottles of 400 ml together with instructions for medical use in a quantity corresponding to the number of primary packagings, placed in a cardboard box for consumer packaging with a cardboard lining or in a cardboard box corrugated with gaskets and grilles (sockets).

100, 200, 250, 300, 400, 500, 600, 800, 1000, 2000, 3000 ml in polymer containers formed in the production process from polyolefin film for the manufacture of soft containers for infusion solutions, three-layer coextrusion or polyethylene copolymer film propylene for the manufacture of soft containers for infusion solutions, multilayer polymer or one-piece or separate tubular film APP114 made of polyolefin and polypropylene, and sealed with polycarbonate ports with a stopper made of gray rubber and a cap made of aluminum and propylene to soft containers for infusion solutions or ports made of polypropylene ( systems for sealing polypropylene containers) or into single-use Siflex Pack polypropylene polymer containers with a stopper and adapter for infusion solutions, hemopreservatives, blood substitutes, biological products and water for injection, or into soft polypropylene polymer containers for infusion solutions.

Text is applied to the surface of the container or a label is glued from label or writing paper or from other paper of a quality not lower than specified.

For sale through the pharmacy chain, each polymer container, along with instructions for medical use and guidelines for the use of polymer containers with infusion solution, is packaged in a bag made of polyethylene film or biaxially oriented polypropylene film.

Text is applied to the surface of the film bag using thermal printing.

44 100 ml resin containers, 32 200 ml resin containers, 24 or 28 250 ml resin containers, 20 300 ml resin containers, 16 400 ml resin containers, 12 500 ml resin containers, 10 600 ml resin containers , 8 polymer containers with a volume of 800 ml, 6 polymer containers with a volume of 1000 ml, 4 polymer containers with a volume of 2000 ml, 2 polymer containers with a volume of 3000 ml in bags or without bags (for hospitals) together with instructions for medical use and instructions for the use of polymer containers with infusion solution in an amount corresponding to the number of polymer containers is placed in a cardboard box for consumer packaging or in a corrugated cardboard box.

special instructions

In the event of the development of symptoms such as vomiting, headache, visual disturbances, dizziness , the drug should be stopped and the development of subdural or subarachnoid hemorrhage .

When using the drug, you should monitor blood pressure, diuresis electrolyte levels in the blood.

Features of the use of fillers containing mannitol

Soliderm 2 (stabilized hyaluronic acid 20 mg/ml, mannitol) is used for the correction of superficial and fine wrinkles, crow's feet around the eyes, wrinkles in the forehead and between the eyebrows, perioral wrinkles, and reinforcement of the décolleté area.

The drug Soliderm 4 (stabilized hyaluronic acid 24 mg/ml, mannitol) is intended for volumetric correction of the face, filling wrinkles and folds, replenishing tissue deficiency on the temples and cheekbones, correcting the bridge of the nose, eliminating scars and stretch marks.

The use of Soliderm preparations for injection plastic surgery not only allows increasing the internal volume of tissues, but also helps stimulate neocollagenesis, the expression of connective tissue growth factor, as well as consistent restructuring of the skin. The use of mannitol in Soliderm fillers allows to slow down the process of biodegradation of hyaluronic acid, promotes a more intense and prolonged process of collagen synthesis, restoration of water balance and elasticity of the skin, i.e. its natural rejuvenation and slowing down its aging processes.

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What is more important when choosing a drug: age or morphotype of aging?

There are various recommendations for choosing a drug, including the concentration of hyaluronic acid in it, depending on the age of the patient. But age is not always determined by passport. A personalized approach includes both an assessment of individual genetic characteristics and predispositions, as well as the lifestyle and morphotypological characteristics of the patient.

In accordance with the classification of morphotypes of aging according to I. I. Kolgunenko, tired, deformation, finely wrinkled, muscular and combined types are distinguished.

Owners of the tired morphotype are often thin women with a narrow or oval face, with normal skin in youth and moderately dry in adulthood. People look tired and sleep deprived.

Objectively, there is a decrease in the tone of the soft tissues, the skin is dull, possibly with pigmentation, impaired lymphatic drainage and moderate swelling.

The finely wrinkled morphotype of aging predominates in people of asthenic physique with an oval or rectangular face, which retains its outline with age. With this type, dystrophy of the epidermis, dermis and subcutaneous fat is observed. The skin is dry, thinned, with elements of hyperkeratosis, prone to irritation. Both static and dynamic wrinkles are present.

The deformational morphotype of aging occurs in women with a heavy build and an excess subcutaneous fat layer. Accompanied by oval deformation, sagging of the lower third of the face, swelling and pastiness.

The muscular morphotype predominates in representatives of the Asian race, where a small amount of subcutaneous fat and well-developed facial muscles are genetically determined. With this type, large wrinkles are expressed in facially mobile areas in combination with pigmentation disorders. At the same time, the skin in adulthood remains smoothed, and the oval retains its outline.

Table. Features of the use of Bellarti preparations depending on the morphotype, zone, and condition of the skin.

* Periorbital zone in micropapular technique.

Where is Bellarti made?

It should be noted that Bellarti are produced at the modern Solopharm pharmaceutical plant. Solopharm is the largest pharmaceutical company, a leader in the production of liquid sterile dosage forms in Russia, founded in 2010.

The Solopharm plant was built in 2013 according to international GMP quality standards using clean room technology. The plant has modern high-tech European equipment, the latest heating, ventilation and water treatment systems. This allows us to diversify our products and produce medicines in unique packaging without preservatives. Solopharm has its own R&D department and laboratories, which provide full-cycle pharmaceutical development and carry out quality control of incoming raw materials, all stages of production and output products.

The filling of the Bellarti drug is carried out on the automatic line “Eva” of the German manufacturer Bausch & Strobel.

Eva line producing pre-filled injection syringes