Cílem práce bylo vyvinout antistresové pastilky obsahující 100 mg glycinu a 250 mg magnesium-citrátu získané metodou přímého lisování. Aby bylo možné zvolit optimální složení pomocných látek poskytující dostatečné kvalitativní vlastnosti tabletoviny, mechanickou pevnost tablet a jejich odolnost a pomalé rozpouštění v ústech, bylo připraveno a testováno 27 experimentálních formulací podle frakčního faktoriálního designu latinských čtverců. Pomocné látky použité ve studii byly: Mannogem® EZ, Cellactose® 80 a GalenIQ™ 721 (plniva); Plasdone™ S-630, Kollidon® 90 F a Avicel® PH-101 (suchá pojiva); Metolose® 90SH-4000SR a klovatina guar (gelotvorné látky); PRUV®, Neusilin® US2 a Compritol® 888 CG ATO (antifrakční pomocné látky). Byly zkoumány následující parametry: sypná hustota, Carrův index, oděr, pevnost a doba rozpadavosti in vitro. Pro statistické zpracování byl použit přístup ANOVA, který umožnil odhalit jednotlivé vlivy každé použité pomocné látky a několik interakčních účinků pozorovaných u množství excipientů použitých v této studii. Isomalt (GalenIQ™ 721), kopovidon (Plasdone™ S-630) a glycerylbehenát (Compritol® 888 CG ATO) byly vybrány pro začlenění do konečné formulace lisovaných pastilek.
The aim of this work was to develop anti-stress compressed lozenges containing 100 mg of glycine and 250 mg of magnesium citrate obtained by the direct compression method. To choose optimal excipient composition providing the sufficient pharmaco-technical properties of the tablet blend, mechanical strength of tablets and non-disintegrating, slow-dissolving behavior of compressed lozenges during sucking, 27 experimental formulations according to fractional factorial Latin cube design were prepared and tested. The excipients used in the study were: Mannogem® EZ, Cellactose® 80 and GalenIQ™ 721 (fillers); Plasdone™ S-630, Kollidon® 90 F and Avicel® PH-101 (dry binders); Metolose® 90SH-4000SR and guar gum (gel-forming binders); PRUV®, Neusilin® US2, and Compritol® 888 CG ATO (antifriction excipients). The following parameters were investigated as responses: bulk density, Carr’s index, friability, resistance to crushing, and in vitro disintegration time. ANOVA approach was applied for statistical processing, which allowed to reveal the individual effects of each excipient and several interaction effects observed for the excipient amounts used in this study. Isomalt (GalenIQ™ 721), copovidone (Plasdone™ S-630), and glyceryl behenate (Compritol® 888 CG ATO) were selected to be incorporated in the final formulation of compressed lozenges.
Použití laktobacilů při léčbě a prevenci poruch vaginální mikroflóry, jako je bakteriální vaginóza a vulvovaginální kandidóza, je velmi slibné. Cílem této studie bylo optimalizovat složení a technologii v současné době vyvíjeného léčivého přípravku ІМВ 72-7280 ve formě vaginálních globulí obsahujícího Lactobacillus casei (L. casei). Parametry kontroly kvality byly definovány v souladu se Státním lékopisem Ukrajiny (2. vydání) a zahrnovaly posouzení vzhledu, stejnoměrnost textury, hmotnostní stejnoměrnost a zkoušku rozpadavosti. Obsah laktobacilů byl hodnocen po přípravě a během doby skladování. V rámci studie bylo vybráno vhodné složení a technologie pro přípravu vaginálních globulí s očekávanou skladovací dobou 6 měsíců. Výsledky popsané studie budou použity pro vývoj technologických instrukcí pro extemporózní vaginální pesary s definovanou probiotickou aktivitou.
Lactobacilli use in treatment and prevention of the vaginal microflora disorders, such as bacterial vaginosis and vulvovaginal candidiasis, is highly promising. The objective of this study was is to develop formulation and technology of the extemporal Lactobacillus casei (L. casei) ІМВ В-7280-containing medicinal product in the form of vaginal pessaries. The quality control parameters were defined in accordance with the State Pharmacopeia of Ukraine (2nd edition) and included appearance, uniformity of texture, uniformity of mass and disintegration test. Lactobacilli assay was determined after preparation and within the storage period. Thus, feasible formulation and technology were selected for vaginal pessaries with an expected 6-month shelf life. The results of the hereby described research will be used for technological instruction development for extemporaneous vaginal pessaries with defined probiotic activity.
- Keywords
- vaginální globule,
- MeSH
- Administration, Intravaginal MeSH
- Vaginosis, Bacterial * drug therapy MeSH
- Candidiasis, Vulvovaginal * drug therapy MeSH
- Clinical Studies as Topic MeSH
- Lactobacillus MeSH
- Humans MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
PURPOSE: The purpose of this study was formulation and optimization of vaginal film formulation containing abacavir (ABC), a potent nucleoside reverse transcriptase inhibitor. METHODS: Vaginal films were prepared by solvent evaporation method using hydroxypropyl methylcellulose (HPMC) blended with polyvinyl pyrrolidone (PVP). Various physicochemical parameters of the prepared films such as drug content, thickness, tensile strength, percentage elongation at break, drug polymer interaction, swelling capacity, folding endurance, bio-adhesion, pH, and moisture content were evaluated with morphological studies. In vitro release study and in vivo release study were also performed. RESULTS: Films exhibited favorable physicochemical properties. The in vitro study showed that HPMC-PVP combination can control the release of abacavir through vaginal films with higher amount of PVP in the formulation resulting in an enhanced drug release rate. During the in vivo study in rabbits, systemic absorption of the drug was noted and the films remained intact for long in vagina without causing any sort of irritations. CONCLUSION: Thus, in a nutshell, the findings of our experimental work indicate that such films can be considered as a novel drug carrier system for the treatment of AIDS and other sexually transmitted diseases (STDs), and are suitable for local as well as systemic effects.
- MeSH
- Administration, Intravaginal MeSH
- Chemical Phenomena MeSH
- Dideoxynucleosides administration & dosage pharmacokinetics MeSH
- Rabbits MeSH
- Anti-HIV Agents administration & dosage pharmacokinetics MeSH
- Dosage Forms * MeSH
- Drug Carriers administration & dosage chemistry MeSH
- Drug Compounding * MeSH
- Drug Liberation * MeSH
- Animals MeSH
- Check Tag
- Rabbits MeSH
- Female MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
12 s. ; 32 cm
- MeSH
- Commonwealth of Independent States MeSH
- Health Services Research MeSH
- Research MeSH
- Research Design MeSH
- Health Policy MeSH
- Geographicals
- Commonwealth of Independent States MeSH
- Europe, Eastern MeSH
- Conspectus
- Veřejné zdraví a hygiena
- NML Fields
- management, organizace a řízení zdravotnictví
- veřejné zdravotnictví
- NML Publication type
- publikace WHO
The aim of this study was optimization of spray-drying process conditions for microencapsulation of Turkish oregano extract. Different concentrations of maltodextrin and gum arabic as encapsulating agents (wall material) as well as influence of selected processing variables were evaluated. The optimal conditions were maintained on the basis of the load of main bioactive compounds - ursolic, rosmarinic acids and carvacrol - in prepared microparticles after comparison of all significant response variables using desirability function. Physicomechanical properties of powders such as flowability, wettability, solubility, moisture content as well as product yield, encapsulation efficiency (EE), density, morphology and size distribution of prepared microparticles have been determined. The results demonstrated that the optimal conditions for spray-drying mixture consisted of two parts of wall material solution and one part of ethanolic oregano extract when the feed flow rate was 40 mL/min and air inlet temperature -170 °C. Optimal concentration of wall materials in solution was 20% while the ratio of maltodextrin and gum arabic was 8.74:1.26.
- MeSH
- Gum Arabic MeSH
- Origanum * MeSH
- Drug Compounding * MeSH
- Capsules MeSH
- Desiccation MeSH
- Publication type
- Journal Article MeSH
This study reports the development and validation of a new, simple, and accurate high-performance thin-layer chromatography (HPTLC)-densitomeric method for the determination of nandrolone decanoate in a commercially available injection formulation. Chromatographic analysis was performed on glass CN modified silica gel 60F254 plates developed using n-hexane-ethyl acetate in volume ratio 42.5:7.5 as the mobile phase. Densitometric scanning was carried out at the wavelength of 245 nm. This chromatographic system gave compact spot and a symmetrical peak of nandrolone decanoate with retardation factor (RF) value at 0.57 (±0.02). The linearity of this method with the high correlation coefficient of calibration plot ranges from 0.780 to 12.500 μg/spot. The developed method is characterized by good precision (coefficient of variation CV < 2%) and high accuracy close to 100.3% (R = 99.0%). Values of limits of detection and quantification equal to 0.231 and 0.700 μg/spot, respectively, confirm the sensitivity of the developed method. The analysis of the pharmaceutical formulation of nandrolone decanoate indicates drug content of 50.5 mg/mL and 101.0% in relation to the label claim. This is in good agreement with the recommendation of the International Council for Harmonisation (ICH) guidelines as well as the pharmacopoeial requirements. The low CV value (<1%) of nandrolone decanoate content in the tested injection formulation confirms the suitability of the proposed HPTLC-densitometric method for routine control of this compound in examined pharmaceuticals.
- MeSH
- Chromatography, Thin Layer * methods standards MeSH
- Densitometry * methods standards MeSH
- Pharmaceutical Preparations analysis MeSH
- Nandrolone Decanoate analysis MeSH
- Drug Compounding MeSH
- Reproducibility of Results MeSH
- Sensitivity and Specificity MeSH
- Chromatography, High Pressure Liquid * methods standards MeSH
- Publication type
- Journal Article MeSH
- MeSH
- Humans MeSH
- Religion and Psychology MeSH
- Religion and Science MeSH
- Research trends MeSH
- Research Design MeSH
- Check Tag
- Humans MeSH
- Publication type
- Review MeSH
Prescription opioid abuse is a worldwide growing significant health problem. For that reason, the manufacturing of abuse-deterrent dosage forms is highly important. Alcohol is likely to interact with the drug product and causes a sudden drug liberation (i.e., dose dumping), which possibly results in dangerous side effects and poses a serious safety concern. Thus, it is necessary to develop robust dosage forms that are resistant to the effects of various ethanol concentrations in order to eliminate the risk of immediate release of the entire opioid dose. In this article we review the current information available for drug products and existing formulation strategies that prevent both drug abuse and ethanol-induced dose dumping. These studies may provide insight into how various technologies may differ in their ability to deter opiate drugs abuse.
