1. Development of floating gastroretentive drug delivery systems
Institute of Bioorganic Chemistry,
National Academy of Sciences of Belarus
Mikhail V. Makarenko

2. Gastroesophageal reflux disease (GERD)
GERD, a chronic relapsing disease characterized by morphological change in the esophageal mucosa due to retrograde reflux of gastric contents, esophageal manifested (heartburn, regurgitation, belching, chest pain) and non-esophageal symptoms (asthma, bronchitis, otitis)
It is known that GERD reduces the quality of patients life more significantly than hypertension, complications associated with menopause, angina pectoris and peptic ulcers [Am. J. Med P. 252.]
GERD is rightly considered as a disease of the XXI century, since in recent years incidence of gastric ulcer and duodenal ulcers decreases, and incidence of GERD, increases.

3. Gastroesophageal reflux disease (GERD)
Prevalence - heartburn and other symptoms of GERD in developed countries are found in 20-50% of the population, which not only leads to disruption of the quality of patients life, but also to an increased risk of adenocarcinoma of the esophagus. In Russia people experience heartburn occasionally 48.5% women and 51.4% of men. [Фарматека. Гастроэнтерология, 2006, с. 96.]
In the latest recommendations for the treatment of GERD (Gshtadskoe guidelines for the treatment of GERD, 2008) states that according to a new algorithm for treating a disease initially prescribe drugs from the group of alginates or antacids, and if therapeutic effect was not achieved, moving to combination therapy PPI + alginate / antacid...
Alginate containing antireflux drugs have no significant effect on intragastric pH, production of hydrochloric acid in the stomach and digestion, can be compatible with antisecretory drugs.

4. Pharmacological action
When administered drug reacts with acidic stomach contents forming alginate containing raft on its surface of the stomach contents, which prevents the occurrence of gastroesophageal reflux disease and protect the esophageal mucosa (EM) against gastric acid
The floating alginate raft inhibits reflux, has pepsin binding, enveloping, sorption effect, neutralizes the acid-peptic factor, eliminates pain and dyspeptic syndromes, creates physiological dormancy EM
Prolonged antacid and anti-reflux operation - up to 4.5 hours.
Alginate containing raft,
testing in vitro
ЛС антагонисты MR

5. FROM ANTACIDS TO ANTIREFLUX DRUGS
AlginoMAX - antireflux antacid, aluminum-free. The results of preclinical studies suggest that the drug is not toxic to the animal organism at dosage up to 5.5 g / kg after a single dose, does not have the negative effects.
Patent of Belarus № 17792, 2013;
WO , 2013; EA , 2014; EP , 2014
GEPHALUM - nonabsorbable antacid based on aluminum phosphate gel and pectin. The drug has an acid-adsorbing and enveloping effect.
(M.V. Makarenko et al. Patent of Belarus № 2514, 1998).

6. COMPETITIVE ADVANTAGES*
Drug
Alginate, mg
Active ingredientв,
ANC,
meq
Weight raft, g
Price,
(RUB)
Gaviscon Advance (Reckitt Benckiser Healthcare, UK)
1000
1400
6,0
18,6±8,6
202,4
blister
№16
AlginoMAX ( IBOCH, Belarus)
500
1040
10,8
27,9±1,1
134,0
№14
Gaviscon Liquid suspension (Reckitt Benckiser, UK)
930
8,1
17,9
255,7
Bottle
150 ml
the efficacy and safety of the drug action antireflux
effective treatment using lower doses of the active ingredients compared with a commercially available
the presence of four patents + Know-How
*M.V. Makarenko, S.A. Usanov. Floating drug delivery systems: raft technology. Proceedings of the Belarusian State University, Series of Physiological, Biochemical and Molecular Biology Sciences Vol. 9. № 1. P

7. Analysis of the Russian Pharmaceutical Market
Despite the fact that almost 1/3 of Russia registered the drugs used for the treatment of gastrointestinal diseases associated with the violation of the acidity produced by domestic manufacturers in terms of sales leading foreign companies - their share in January 2015 was 74% (DSM Group, "Monthly retail audit of the pharmaceutical market in the Russian Federation").
The pharmaceutical market of anti-ulcer drugs (Gaviscon is included in the TOP-10 brands) in Russia in 2009 amounted to 37, 9 billion $.
Value of the minimum (14 days) treatment Geviscon - 28,2 $, claimed preparations $. At least 13% of Russians are diagnosed with acid disorders. Single course of treatment will provide income $.
Release of promising drugs will not only expand the arsenal of anti-ulcer drugs, but also is able to increase the demand. The user will receive an affordable, effective and safe drug, and producer - profits.

8. PROPOSITION
Development of promising drugs with pharmaceutical active ingredients (antacids, antibacterial, antiviral, proton pump inhibitors and H. pylori, etc.)
Development of alternative dosage forms (sachets, suspension)
Partner is required to enter the pharmaceutical market of Russia, CIS and Asia (registration, advertising, branding)
AlginoMAX, blisters № 14

9. Supervisor of the project
team
PARTNERSHIP
Supervisor of the project
S.A. Usanov
Doctor of Chemical Sciences, Corresponding Member of National Academy of Science, Professor articles, 20 patents
Project coordinator
M.V. Makarenko
Senior Researcher. 82 articles, 29 patents
Analysis and testing
A.V. Yantsevich
Ph.D, Head of the department of protein engineering, 36 articles
АCADEMPHARM

10. We invite you to cooperate
Development of floating gastroretentive drug delivery systems
Supervisor of the project
S.A. Usanov
Project coordinator
M.V. Makarenko