Introduction. Prevention and treatment of benign prostatic diseases remain one of the pressing problems of modern medicine. Rectal suppositories are one of the main dosage forms used in urological practice. In order to provide the necessary organoleptic, physico-chemical, technological and osmotic properties, into their composition surfactants are introduced. The aim of this work was to select the optimal surfactant and to substantiate its concentration in the suppositories with indole-3-carbinol and meloxicam. Materials and methods. As the research objects have been selected: the carrier-PEO-base, emulsifiers-Montanox 80, Lanette SX, Cremophor RH-40, Myverol 18-04K NF, soy lecithin. The investigation of organoleptic (appearance, absence of inclusions and stratifications, homogeneity at the cut), physico-chemical (pH, time of decomposition), technological (resistance to destruction) and osmotic (dialysis through a semipermeable membrane) properties of the suppositories by the methods of SPU has been performed. Results and discussion. Model specimens of suppositories with Montanox 80, Lanette SX and soy lecithin comply with the requirements of the SPU for all quality indices. In order to reduce the osmotic activity of the developed suppositories, the addition of Montanox 80 emulsifier in the amount of 3 % was found to be most appropriate, which would not result in dehydration and overdrying of the rectum mucosa. Conclusions. Experimental researches have established that the optimal surfactant in the composition of the suppositories with indole-3-carbinol and meloxicam, which provides the necessary qualitative characteristics and reduces the hyperosmotic properties of the polyethylene oxide base, is Montanox 80 in the amount of 3 %.
Постанова проблеми. Нагальною про-блемою сучасного вітчизняного фармацев-тичного ринку є забезпечення української спільноти якісними, доступними та конкурен-тоспроможними лікарськими засобами (ЛЗ). З огляду на тривалу соціально-економічну кризу в Україні процес виведення на ринок нових ЛЗ, забезпечення їх доступності для усіх верств населення залишаються на сьо-годні досить важливою проблемою в систе-мі охорони здоров'я країни. Особливої ак-туальності набувають питання, що стосу-ються виробництва й просування вітчиз-няних антигеморагічних ЛЗ та їх дефіциту на ринку, оскільки це забезпечить значно нижчу їх вартість у порівнянні із зарубіж-ними аналогами та сприятиме фізичній і соціально-економічній доступності ліків.С. А. Куценко -доктор фарм. наук, доцент, доцент кафедри заводської технології ліків Національного фармацевтичного університету (м. Харків)
Significant prevalence of dental pathologies among different age groups of the population of Ukraine dictates the need to find new effective medicines used in the treatment of oral cavity diseases. The choice of a dosage form and the optimal composition of the active pharmaceutical ingredients introduced in it to provide the necessary therapeutic effect is of importance in the treatment of periodontal diseases. For local treatment in dentistry gels are widely used; due to formation of aqueous internal structures they can include various chemotherapeutic substances in their composition, which makes it possible to obtain a dosage form with the multi-profile action. Considering the above, the research on developing the composition and technology of the dental gel with "Phytodent" tincture (PJSC "CPP Red Star", Ukraine), choline salicylate 80 % (Basf Pharma, Switzerland) and lidocaine hydrochloride (Societa Italiana Medicinali Scandicci, Italy) has been conducted.Aim. To select the optimal gel base from the solutions of polymers of the semi-synthetic and synthetic origin tested in different concentrations by studying the biopharmaceutical and adhesion characteristics of six samples of gels.Materials and methods. The biopharmaceutical studies were performed by the method of direct diffusion in 2 % agar gel containing iron (III) chloride solution as an indicator. The degree of bioavailability of the amount of active substances from gels was determined by the diameter of the colored zone. The adhesive ability was studied using an electronic dynamometer.Results and discussion. It has been found that addition of mucosal adhesives to a gel-former provides the prolonged action to gels and increases their adhesion ability.Conclusions. The results of the biopharmaceutical studies have not been allowed determining the statistically reliable advantage of any of the gel samples. Based on the results of their adhesion ability the gel compositions with the best adhesion characteristics have been found; they can be recommended for further screening studies on creation of a new dental gel.Key words: periodontal diseases; dental gels; polymer gel base; mucosal adhesives; bioavailability; adhesion ability Ю. С. Маслій, О. А. Рубан Вивчення біофармацевтичних і адгезійних характеристик стоматологічного гелюЗначна поширеність стоматологічних патологій серед різних вікових груп населення України диктує необхід-ність пошуку нових ефективних лікарських засобів, що застосовуються в терапії захворювань ротової порожнини. Важливе значення в терапії захворювань пародонту має вибір лікарської форми і оптимального складу актив-них фармацевтичних інгредієнтів, введених у неї з метою забезпечення необхідного терапевтичного ефекту. Для місцевого лікування в стоматології широко використовують гелі, які завдяки утворенню водних внутрішніх структур дозволяють включати до свого складу різні хіміотерапевтичні речовини, що обумовлює можливість отримання однієї лікарської форми багатопрофільної дії. Враховуючи вищесказане, нами були проведені до-слідження...
Aim: The aim is to study the development of a methodology for the quantitative determination of meloxicam and indole-3-carbinol in the developed rectal suppositories, which would allow the effects of the matrix, placebo, and accompanying impurities on the course of the determination to be cutoff. Materials and Methods: Indole-3-carbinol (Sigma-Aldrich Co., USA) and meloxicam (Boehringer Ingelheim GmbH, Germany) as well as developed rectal suppositories with a combination of given active pharmaceutical ingredients in the amount for 1 suppository: Indole-3-carbinol-0.2 g and meloxicam-0.0075 g were used In carrying out the studies, meloxicam PRS was used, corresponding to the requirements of the European Pharmacopoeia. To determine the content of indole-3-carbinol, a reagent with a purity of at least 99% was used. To calculate the quantitative content of meloxicam and indole-3-carbinol, the homogeneity values obtained for the 10 samples studied are used. The measurements were carried out by high-performance liquid chromatography (HPLC) according to SPU, supp. 1, 2.2.29, N. The validation of the methodology was carried out in accordance with the requirements of SPU according to individual validation characteristics: Specificity, linearity, repeatability, precision, accuracy, and intralaboratory precision. Results and Discussion: According to the developed technique, the quantitative determination of meloxicam and indole-3-carbinol in the composition of rectal suppositories has been studied. The following results were obtained: With the content of meloxicam in one dosage unit of the test preparation is 0.0078 g and the content of indole-3-carbinol-0.205 g, which indicates the validity of the proposed procedure for the quantification of active substances in suppositories for the prevention and treatment of benign prostatic diseases. Conclusions: In the course of the study, a HPLC technique with a gradient elution mode has been developed. It has been established that the selected chromatographic conditions allow not only quantitatively determine the substances under investigation in the finished dosage form but also estimate the uniformity of their distribution. The validation of the developed method has been carried out, and its suitability for simultaneous quantitative determination of both meloxicam and indole-3-carbinol in a dosage form was proved.
Introduction: Diseases of the prostate gland occupy one of the main places in the structure of urological diseases and acquire ever increasing social significance. They are the most common diseases associated with aging in men. In conservative treatment of patients with diseases of the prostate gland, considering pathogenetic mechanisms, medicines of different directionalities are used, eliminating infectious agents, correcting the immune status, contributing to the regression of the inflammatory process and restoring the functional activity of the prostate. Materials and Methods: Indole-3-carbinol (Sigma-Aldrich Co., USA) and meloxicam (Boehringer Ingelheim GmbH, Germany) were chosen as the study objects. Studies of the active pharmaceutical ingredients (APIs) solubility were made, their crystallographic and thermogravimetric analyses. Results and Discussion: In the work, it has been substantiated the composition of rectal suppositories for the treatment of benign prostatic diseases using a combination of indole-3-carbinol and meloxicam, which possess anti-inflammatory, analgesic, and antibacterial properties and also contribute to the restoration of the hormonal background of men with age-related changes and activation of regeneration processes of the injured organ. A microscopic and thermogravimetric analysis of selected APIs was carried out, and their solubility in aqueous and non-aqueous solvents was investigated. Conclusions: Based on research results, the optimal auxiliary substances were selected for rational introduction of substances into the suppository base -polyethylene oxide-400, Tween-80. The results of thermogravimetric analysis have proven the thermostability of the investigated APIs in the temperature range the suppository bases melting.
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