The dissertation is devoted to the development of the composition,
technology and research of medicinal products (drugs) in the form of lidocaine
cream and ointment hydrochloride, ibuprofen, methyluracil and CO2 chamomile
extract with an anesthetic, anti-inflammatory, antimicrobial effect for the treatment
of wounds based on a complex of pharmacotechnological, physico-chemical,
structural-mechanical, biopharmaceutical, microbiological and pharmacological
studies.
An analytical review of data from literary sources on etiology,
pathogenesis, and modern approaches to wound treatment was conducted. Taking
into account the etiopathogenesis of the wound process and the fact that the
existing drugs are mainly monocomponent and do not take into account the course
of the wound process, we determined, on the basis of bibliosemantic and analytical
methods of research, the relevance of the development of multicomponent drugs
using substances of synthetic and plant origin, which were effective and safe for
treatment of the wound process.
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During the analytical review of data from literary sources, the expediency of
using antimicrobial, anti-inflammatory (CO2 chamomile extract), anesthetic
(lidocaine) substances was determined hydrochloride), anti-inflammatory
(ibuprofen) and regenerating, wound-healing (methyluracil) action. Such a
combination of active pharmaceutical ingredients (APIs) in the composition of
pharmaceuticals will promote wound healing in a shorter period of treatment due
to their synergistic action, which will provide an opportunity to use API data in the
development of soft pharmaceuticals (MLZ) for the treatment of skin wounds of
various etiologies.
As a result of the marketing analysis of the pharmaceutical market of
Ukraine, it was determined that import substitution will continue to be an urgent
problem in pharmacy, which is due to the overwhelming number of ready-made
drugs: 3,841 items of domestic production and 7,647 of foreign production.
Analysis of the range of drugs containing lidocaine hydrochloride, showed the
presence of 66 names of drugs in the form of solutions, solid LF, sprays and soft
LF (MLF) - 12 names. 26 active pharmaceutical ingredients (APIs) belonging to
different pharmacological groups are included in the 66 names of drugs, including
three containing APIs of plant origin. The number of auxiliary substances in the
composition of 12 names of soft drugs is equal to 46: surface-active substances
(surfactants), polymers, hydrophilic non-aqueous solvents (HNR), etc. Medicines
containing lidocaine hydrochloride , belong to 8 groups and 12 subgroups of the
ATS classification system.
The number of drugs containing methyluracil includes 17 items and are
presented in the form of solids and MLF (8 items). Of the 8 names of MLZ in the
form of an ointment, Levomikol ointment (6 names) is represented by various
manufacturers. The 8 names of soft drugs include 4 APIs: trimecaine ,
sulfadimethoxine, miramistin and chloramphenicol. And auxiliary substances are
PEG 400, PEG 1500, PG, poloxamer , cetyl alcohol , stearyl alcohol and purified
water. Medicinal products containing methyluracil belong to ATC group D -
Dermatological products.
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Ibuprofen is the next API that we plan to introduce into the composition of
the combined medicine. The number of registered drugs containing ibuprofen is
147 names, of which 8 are in the form of soft drugs, which is 5.44% of all drugs.
Among the 8 names of MLZ, 50% are monopreparations: 1 cream and 3 gels. The
other 50% contain combinations of ibuprofen with levomenthol (3 names) and
ibuprofen with glucosamine hydrochloride and allantoin (1 name). It should be
noted that menthol and levomenthol are included as excipients in LF in two drugs.
Medicines containing ibuprofen belong to 1 group and 4 subgroups of the ATS
classification system.
The number of auxiliary substances included in the composition of MLZ is:
ointments - 20, creams - 40 and gels - 27 items. The largest amount of auxiliary
substances is used in the composition of the cream, the smallest - in the
composition of the gel. This is explained by the LF itself and depends on the
dispersion medium of the LF.
