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1.
Hydroxyzine HCl is used in oral formulations for the treatment of urticaria and atopic dermatitis. Dizziness, blurred vision,
and anticholinergic responses, represent the most common side effects. It has been shown that controlled release of the drug
from a delivery system to the skin could reduce the side effects while reducing percutaneous absorption. Therefore, the aim
of the present study was to produce an effective drug-loaded dosage form that is able to control the release of hydroxyzine
hydrochloride into the skin. The Microsponge Delivery System is a unique technology for the controlled release of topical
agents, and it consists of porous polymeric microspheres, typically 10–50 μm in diameter, loaded with active agents. Eudragit
RS-100 microsponges of the drug were prepared by the oil in an oil emulsion solvent diffusion method using acetone as dispersing
solvent and liquid paraffin as the continuous medium. Magnesium stearate was added to the dispersed phase to prevent flocculation
of Eudragit RS-100 microsponges. Pore inducers such as sucrose and pregelatinized starch were used to enhance the rate of
drug release. Microsponges of nearly 98% encapsulation efficiency and 60–70% porosity were produced. The pharmacodynamic effect
of the chosen preparation was tested on the shaved back of histamine-sensitized rabbits. Histopathological studies were driven
for the detection of the healing of inflamed tissues. 相似文献
2.
The purpose of the research was to evaluate Sterculia foetida gum as a hydrophilic matrix polymer for controlled release preparation. For evaluation as a matrix polymer; characterization
of Sterculia foetida gum was done. Viscosity, pH, scanning electronmicrographs were determined. Different formulation aspects considered were:
gum concentration (10–40%), particle size (75–420 μm) and type of fillers and those for dissolution studies; pH, and stirring
speed were considered. Tablets prepared with Sterculia foetida gum were compared with tablets prepared with Hydroxymethylcellulose K15M. The release rate profiles were evaluated through
different kinetic equations: zero-order, first-order, Higuchi, Hixon-Crowell and Korsemeyer and Peppas models. The scanning
electronmicrographs showed that the gum particles were somewhat triangular. The viscosity of 1% solution was found to be 950
centipoise and pH was in range of 4–5. Suitable matrix release profile could be obtained at 40% gum concentration. Higher
sustained release profiles were obtained for Sterculia foetida gum particles in size range of 76–125 μm. Notable influences were obtained for type of fillers. Significant differences were
also observed with rotational speed and dissolution media pH. The in vitro release profiles indicated that tablets prepared from Sterculia foetida gum had higher retarding capacity than tablets prepared with Hydroxymethylcellulose K15M prepared tablets. The differential
scanning calorimetry results indicated that there are no interactions of Sterculia foetida gum with diltiazem hydrochloride. It was observed that release of the drug followed through surface erosion and anomalous
diffusion. Thus, it could be concluded that Sterculia foetida gum could be used a controlled release matrix polymer. 相似文献
3.
In this study, we have formulated chitosan-coated sodium alginate microparticles containing meloxicam (MLX) and aimed to investigate
the correlation between in vitro release and in vivo absorbed percentages of meloxicam. The microparticle formulations were prepared by orifice ionic gelation method with two
different sodium alginate concentrations, as 1% and 2% (w/v), in order to provide different release rates. Additionally, an oral solution containing 15 mg of meloxicam was administered
as the reference solution for evaluation of in vitro/in vivo correlation (ivivc). Following in vitro characterization, plasma levels of MLX and pharmacokinetic parameters [elimination half-life (t
1/2), maximum plasma concentration (C
max), time for C
max (t
max)] after oral administration to New Zealand rabbits were determined. Area under plasma concentration–time curve (AUC0–∞) was calculated by using trapezoidal method. A linear regression was investigated between released% (in vitro) and absorbed% (in vivo) with a model-independent deconvolution approach. As a result, increase in sodium alginate content lengthened in vitro release time and in vivo t
max value. In addition, for ivivc, linear regression equations with r
2 values of 0.8563 and 0.9402 were obtained for microparticles containing 1% and 2% (w/v) sodium alginate, respectively. Lower prediction error for 2% sodium alginate formulations (7.419 ± 4.068) compared to 1%
sodium alginate formulations (9.458 ± 5.106) indicated a more precise ivivc for 2% sodium alginate formulation. 相似文献
4.
Mohsin Shaikh Huihui Zhang Hongyuan Wang Xiuli Guo Yunmei Song Jagat Rakesh Kanwar Sanjay Garg 《AAPS PharmSciTech》2017,18(1):130-137
Esophageal cancer (EC) mostly affects the elderly population and is frequently diagnosed at an advanced stage. Self-expanding metal stents (SEMS) are the most popular mode of palliation, but they are associated with reocclusion caused by tumor growth. To overcome this problem, docetaxel (DTX)-loaded polyurethane formulations were prepared for stent application. The films were evaluated against the cancer cell lines, OE-19 and OE-21, and normal esophageal cell line Het-1A. The DTX and the formulations were evaluated in vitro for the cytotoxicity and in vivo in nude mice. It was found that DTX and the formulations have a weak activity against the EC cell lines and an even weaker activity against Het-1A cell line. Preliminary in vivo studies showed skin toxicity in nude mice necessitating modification of the formulation. Reevaluation in a mouse xenograft model resulted in toxicity at high dose formulations while the low dose formulation exhibited modest advantage over commercial IV formulation; however, there was no significant difference between the commercial IV and blank formulation. DTX combination with an anti-cancer agent having complementary mode of action and non-overlapping toxicity could yield better outcome in future. 相似文献
5.
Xiao-Long Huang Bo Yang Chun-Gen Hu Jia-Ling Yao 《Plant Cell, Tissue and Organ Culture》2009,99(2):209-215
Inflorescence induction and morphogenesis of regenerated flowers were investigated in vitro in Dioscorea zingiberensis C. H. Wright. Inflorescence induction was influenced by the type and concentration of phytohormones. When floral bud explants
were incubated on a Murashige and Skoog medium containing a combination of 2.0 mg l−1 6-benzyladenine and 0.5 mg l−1 indole-3-butyric acid, the highest frequency of inflorescence induction was observed. However, in the presence of gibberellic
acid, induction efficiency was reduced although node length of inflorescence was increased. Ontogenetic studies revealed that
the inflorescence primordia originated directly from axillary epidermal cells of the perianth and bract of the explants after
7 days. In vitro, male flowers developed normally and blossomed after 90–100 days. In addition, some bisexual flowers were
observed. These results demonstrated that there were differences in sexual differentiation of floral buds in vitro compared
with that in vivo. 相似文献
6.
Liao CW Lin SH Lin PY Chiou HY Chang WF Weng CN 《Applied microbiology and biotechnology》2004,65(3):295-300
To overcome the limitations of injection administration to vaccinate neonatal piglets against diarrheal disease, an oral vaccine needs to be developed. Enteric microspheres of oral vaccines were developed by a co-spray drying process based on formalin-inactivated enterotoxigenic Escherichia coli antigens with various encapsulating materials. The encapsulating efficiencies of ECN7m, ECN14m and ECN22m (vaccine microsphere formulations) tested by extraction procedure are high, more than 85%. To assess enteric characteristics, an in vitro dissolution test was performed with microspheres. Formulations with ethylcellulose ECN14m and ECN22m allow controlled release in a neutral or basic environment and resisted acid damage. In all cases, 95% of the E. coli protein was released within 2 h at pH 6.8–7, but there was no release at pH 1.5–2. However, ECN7m was less acid-resistant and had lower release at low pH. In animal immunization tests, oral immunization with microspheres of formulations ECN14 and ECN22m effectively evoked both systemic IgG and mucosal IgA responses against E. coli whole cell antigens in mice. In the mice challenge test, orally administrable ECNm14 (12 mg) or ECN22m (12.6 mg) vaccine (i.e., encapsulating 3.0×109 cfu inactive bacterial mass) provided good protection from infection in animals. 相似文献
7.
The purpose of this research was to design oral controlled release (CR) matrix tablets of zidovudine (AZT) using hydroxypropyl
methylcellulose (HPMC), ethyl cellulose (EC) and carbopol-971P (CP) and to study the effect of various formulation factors
on in vitro drug release. Release studies were carried out using USP type 1 apparatus in 900 ml of dissolution media. Release kinetics
were analyzed using zero-order, Higuchi’s square root and Ritger–Peppas’ empirical equations. Release rate decreased with
increase in polymer proportion and compression force. The release rate was lesser in formulations prepared using CP (20%)
as compared to HPMC (20%) as compared to EC (20%). No significant difference was observed in the effect of pH of dissolution
media on drug release from formulations prepared using HPMC or EC, but significant difference was observed in CP based formulations.
Decrease in agitation speed from 100 to 50 rpm decreased release rate from HPMC and CP formulations but no significant difference
was observed in EC formulations. Mechanism of release was found to be dependent predominantly on diffusion of drug through
the matrix than polymer relaxation incase of HPMC and EC formulations, while polymer relaxation had a dominating influence
on drug release than diffusion incase of CP formulations. Designed CR tablets with pH independent drug release characteristics
and an initial release of 17–25% in first hour and extending the release up to 16–20 h, can overcome the disadvantages associated
with conventional tablets of AZT. 相似文献
8.
A Luquita L Urli MJ Svetaz AM Gennaro ME Giorgetti G Pistone R Volpintesta S Palatnik M Rasia 《Journal of biomedical science》2010,17(1):8
Background
Hyaluronic acid (HA) is present in many tissues; its presence in serum may be related to certain inflammatory conditions, tissue damage, sepsis, liver malfunction and some malignancies. In the present work, our goal was to investigate the significance of hyaluronic acid effect on erythrocyte flow properties. Therefore we performed in vitro experiments incubating red blood cells (RBCs) with several HA concentrations. Afterwards, in order to corroborate the pathophysiological significance of the results obtained, we replicated the in vitro experiment with ex vivo RBCs from diagnosed rheumatoid arthritis (RA) patients, a serum HA-increasing pathology. 相似文献9.
Xin Li Hui-Ying Yu Yi-Feng Lin Hong-Mei Teng Lei Du Guo-Gang Ma 《Biotechnology letters》2010,32(10):1487-1495
The morphological effects of CF66I, an antifungal compound produced by Burkholderia cepacia, on growing hyphae of Fusarium oxysporum were studied by fluorescence microscopy (FM) and transmission electron microscopy (TEM). At 20 μg/ml, CF66I strongly inhibited
growth and induced significant changes of the hyphal morphology. These changes included swelling of hyphae with considerable
thickening cell wall and abnormal chitin deposition, which was indicative of the alterations in cell wall structure. Furthermore,
fluorescein diacetate (FDA) staining indicated the loss of intracellular esterase activity. CF66I probably inhibits fungal
growth by interfering with the cell metabolic pathways. At 120 μg/ml, CF66I killed F. oxysporum (accompanied by propidium iodide permeation, intracellular cytoplasm leakage and crushing of hyphal tips), probably by direct
damage to the cell membrane. Thus, there are two different antifungal mechanisms of CF66I, depending on its concentration,
and further studies on this compound might be useful for us to develop a new class of antifungal agents. 相似文献
10.
Nongporn Hutadilok-Towatana Wantana Reanmongkol Pharkphoom Panichayupakaranant 《Journal of applied phycology》2010,22(5):599-605
In this study, the methanol extract of Arthrospira (Spirulina) platensis was examined for acute and subchronic toxicities. The extract did not produce any sign of toxicity within 7 days after feeding
it at a single high dose of 6 g kg−1 body weight to female and male Swiss mice. For the subchronic toxicity test, the extract at doses of 6, 12, and 24 mg kg−1 body weight was orally administered to six male and six female Wistar rats daily for 12 weeks. Throughout the study period,
we did not observe any abnormalities on behavior, food and water intakes, and health status among the treated animals. The
hematology and clinical chemistry parameters of treated groups did not significantly differ from those of the controls in
both sexes. Postmortem examination of the test groups also showed no abnormalities in both gross and histological findings.
These results thus suggest that the methanol extract of A. platensis did not cause acute or subchronic toxicity in our experimental animals. 相似文献
11.
Valsartan orodispersible tablets have been developed at 40-mg dose, with the intention of facilitating administration to patients
experiencing problems with swallowing and hopefully, improving its poor oral bioavailability. Work started with selecting
drug compatible excipients depending on differential scanning calorimetric analysis. A 33 full factorial design was adopted for the optimization of the tablets prepared by freeze-drying technique. The effects of
the filler type, the binder type, and the binder concentration were studied. The different tablet formulas were characterized
for their physical properties, weight variation, disintegration time, surface properties, wetting properties, and in vitro dissolution. Amongst the prepared 27 tablet formulas, formula number 6 (consisting of 4:6 valsartan:mannitol and 2% pectin)
was selected to be tested in vivo. Oral bioavailability of two 40 mg valsartan orodispersible tablets was compared to the conventional commercial tablets after
administration of a single dose to four healthy volunteers. Valsartan was monitored in plasma by high-performance liquid chromatography.
The apparent rate of absorption of valsartan from the prepared tablets (C
max = 2.879 μg/ml, t
max = 1.08 h) was significantly higher than that of the conventional tablets (C
max = 1.471 μg/ml, t
max = 2.17 h), P ≤ 0.05. The relative bioavailability calculated as the ratio of mean total area under the plasma concentration–time curve
for the orodispersible tablets relative to the conventional ones was 135%. The results of the in vivo study revealed that valsartan orodispersible tablets would be advantageous with regards to improved patient compliance, rapid
onset of action, and increase in bioavailability. 相似文献
12.
Two 60-day experiments were conducted to study the influence of photon flux density (PFD) and temperature on the attachment
and development of Gloiopeltis tenax and Gloiopeltis furcata tetraspores. In the first experiment, tetraspores of the two Gloiopeltis species were incubated at five temperature ranges (8°C, 12°C, 16°C, 20°C, 24°C) under a constant PFD of 80 μmol photons m−2 s−1 with a photoperiod of 12:12. In a second experiment, tetraspores were incubated under five PFD gradients (30, 55, 80, 105,
130 μmol photons m−2 s−1) at a constant temperature of 16°C with a photoperiod of 12:12. Maximum density of attached tetraspores was observed at 16°C
for both species. Maximum per cent of spore germinating into disc was recorded at 12–16°C for G. tenax and 8–12°C for G. furcata. Maximum per cent of discs producing erect axes for G. tenax and G. furcata were recorded at 24°C and 20°C, respectively. Light had no significant effect on tetraspore attachment and developing into
disc, but it affected the growth, sprouting and survival of its discs. Under 30–55 μmol photons m−2 s−1, the discs of the two species of Gloiopeltis did not form thallus until the end of the experiment. Optimum PFD range for G. tenax discs was 80–105 μmol photons m−2 s−1, whilst it was 80–130 μmol photons m−2 s−1 for G. furcata. Results presented in this study are expected to assist the progress of artificial seeding of Gloiopeltis. 相似文献
13.
In this study, nanovesicles were developed for brimonidine tartrate by film hydration technique and dispersed in viscous carbopol
solution for ocular delivery. Scanning electron microscopy revealed spherical shape of the vesicles. As high as 32.27% drug
entrapment efficiency was achieved depending upon the surfactant/cholesterol molar ratio (7:4 to 7:8). The vesicles were in
the size range of 298.0–587.9 nm. Release study showed a biphasic drug-release pattern for the lyophilized vesicular formulation
in buffered saline solution, i.e., initial burst release followed by gradual release over the period of 8 h. On contrary,
the isolated vesicles reduced the burst effect in 3 h by two to three times and the drug release was comparatively slower
at the intermediate ratio in both cases. With variation in cholesterol content, the drug release followed either first order
or Higuchi’s kinetics. Physically the lyophilized vesicular formulations were more stable at refrigerated temperature. DSC
and X-RD analyses indicated loss of drug crystallinity in the vesicles. FTIR spectroscopy did not reveal any interaction between
drug and excipients. The lyophilized formulation showed better ocular hypotensive activity than marketed drops on albino rabbits
and in vivo efficacy was sustained up to 7.5 h. Furthermore, the formulation was found to be non-irritant to the rabbit eye. Hence, the
lyophilized vesicles, when dispersed in viscous carbopol solution, had the potential in reducing dosing frequency and could
improve patient compliance. 相似文献
14.
Zheng-Jun Li Lei Cai Qiong Wu Guo-Qiang Chen 《Applied microbiology and biotechnology》2009,83(5):939-947
NAD kinase was overexpressed to enhance the accumulation of poly(3-hydroxybutyrate) (PHB) in recombinant Escherichia coli harboring PHB synthesis pathway via an accelerated supply of NADPH, which is one of the most crucial factors influencing
PHB production. A high copy number expression plasmid pE76 led to a stronger NAD kinase activity than that brought about by
the low copy number plasmid pELRY. Overexpressing NAD kinase in recombinant E. coli was found not to have a negative effect on cell growth in the absence of PHB synthesis. Shake flask experiments demonstrated
that excess NAD kinase in E. coli harboring the PHB synthesis operon could increase the accumulation of PHB to 16–35 wt.% compared with the controls; meanwhile,
NADP concentration was enhanced threefold to sixfold. Although the two NAD kinase overexpression recombinants exhibited large
disparity on NAD kinase activity, their influence on cell growth and PHB accumulation was not proportional. Under the same
growth conditions without process optimization, the NAD kinase-overexpressing recombinant produced 14 g/L PHB compared with
7 g/L produced by the control in a 28-h fermentor study. In addition, substrate to PHB yield Y
PHB/glucose showed an increase from 0.08 g PHB/g glucose for the control to 0.15 g PHB/g glucose for the NAD kinase-overexpressing strain,
a 76% increase for the Y
PHB/glucose. These results clearly showed that the overexpression of NAD kinase could be used to enhance the PHB synthesis. 相似文献
15.
Kavitha P Ramesh R Bupesh G Stalin A Subramanian P 《In vitro cellular & developmental biology. Animal》2011,47(10):698-706
The potential protective role of Tribulus terrestris in acetaminophen-induced hepatotoxicity in Oreochromis mossambicus was investigated. The effect of oral exposure of acetaminophen (500 mg/kg) in O. mossambicus at 24-h duration was evaluated. The plant extract (250 mg/kg) showed a remarkable hepatoprotective activity against acetaminophen-induced
hepatotoxicity. It was judged from the tissue-damaging level and antioxidant levels in liver, gill, muscle and kidney tissues.
Further acetaminophen impact induced a significant rise in the tissue-damaging level, and the antioxidant level was discernible
from the enzyme activity modulations such as glutamate oxaloacetic transaminase, glutamate pyruvic transaminase, alkaline
phosphatase, acid phosphatase, glucose-6-phosphate dehydrogenase, lactate dehydrogenase, superoxide dismutase, catalase, glutathione
peroxidase, glutathione reductase, glutathione S-transferase, lipid peroxidase and reduced glutathione. The levels of all
these enzymes have significantly (p < 0.05) increased in acetaminophen-treated fish tissues. The elevated levels of these enzymes were significantly controlled
by the treatment of T. terrestris extract (250 kg/mg). Histopathological changes of liver, gill and muscle samples were compared with respective controls.
The results of the present study specify the hepatoprotective and antioxidant properties of T. terrestris against acetaminophen-induced toxicity in freshwater fish, O. mossambicus. 相似文献
16.
Recently, the prenyltransferase SirD was found to be responsible for the O-prenylation of tyrosine in the biosynthesis of sirodesmin PL in Leptosphaeria maculans. In this study, the behavior of SirD towards phenylalanine/tyrosine and tryptophan derivatives was investigated. Product
formation has been observed with 12 of 19 phenylalanine/tyrosine derivatives. It was shown that the alanine structure attached
to the benzene ring and an electron donor, e.g., OH or NH2, at its para-position are essential for the enzyme activity. Modifications were possible both at the side chain and the benzene ring.
Enzyme products from seven phenylalanine/tyrosine derivatives were isolated and characterized by MS and NMR analyses including
HSQC and HMBC and proven to be O- or N-prenylated derivatives at position C4 of the benzene rings. K
M
values of six selected derivatives were found in the range of 0.10–0.68 mM. Catalytic efficiencies (K
cat/K
M
) were determined in the range of 430–1,110 s−1·M−1 with l-tyrosine as the best substrate. In addition, 7 of 14 tested tryptophan analogs were also accepted by SirD and converted to
C7-prenylated derivatives, which was confirmed by comparison with products obtained from enzyme assays using a 7-dimethylallyltryptophan
synthase 7-DMATS from Aspergillus fumigatus. 相似文献
17.
Inger-Marie E. Vilcins Julie M. Old Elizabeth Deane 《Experimental & applied acarology》2009,49(3):229-242
Three Australian native animal species yielded 60 samples composed of three indigenous ticks. Hosts included twelve koalas,
two echidnas and one wombat from Victoria, and ticks were of the species Ixodes tasmani (n = 42), Bothriocroton concolor (n = 8) and B. auruginans (n = 10), respectively. PCR screening and sequencing detected a species of Coxiella, sharing closest sequence identity to C. burnetii (>98%), in all B. auruginans, as well as a species of Rickettsia, matching closest to R. massiliae, in 70% of the same samples. A genotype sharing closest similarity to Rickettsia bellii (>99%) was identified in three female B. concolor collected from one of the echidnas. Three samples of I. tasmani, taken from three koalas, yielded different genotypes of Rickettsiella. These results represent the first detection of the three genera in each tick species and identify a high level of previously
undetected bacterial diversity in Australian ticks. 相似文献
18.
A genetic transformation system has been developed for callus cells of Crataegus
aronia using Agrobacterium
tumefaciens. Callus culture was established from internodal stem segments incubated on Murashige and Skoog (MS) medium supplemented with
5 mg l−1 Indole-3-butyric acid (IBA) and 0.5 mg l−1 6-benzyladenine (BA). In order to optimize the callus culture system with respect to callus growth and coloration, different
types and concentrations of plant growth regulators were tested. Results indicated that the best average fresh weight of red
colored callus was obtained on MS medium supplemented with 2 mg l−1 2,4-dichlorophenoxyacetic acid (2,4-D) and 1.5 mg l−1 kinetin (Kin) (callus maintenance medium). Callus cells were co-cultivated with Agrobacterium harboring the binary plasmid pCAMBIA1302 carrying the mgfp5 and hygromycin phosphotransferase (hptII) genes conferring green fluorescent protein (GFP) activity and hygromycin resistance, respectively. Putative transgenic calli
were obtained 4 weeks after incubation of the co-cultivated explants onto maintenance medium supplemented with 50 mg l−1 hygromycin. Molecular analysis confirmed the integration of the transgenes in transformed callus. To our knowledge, this
is the first time to report an Agrobacterium-mediated transformation system in Crataegus
aronia. 相似文献
19.
Daniela Soares dos Santos Vívian Tamaki Catarina Carvalho Nievola 《In vitro cellular & developmental biology. Plant》2010,46(6):524-529
Acanthostachys strobilacea (Schult. f.) Klotzsch is an ornamental species of Bromeliaceae that may show an elongated stem when cultivated in vitro. This work reports a micropropagation protocol for A. strobilacea using nodal segments. Seeds were placed in Murashige and Skoog’s medium with macronutrients diluted to 1/5. Nodal segments
isolated from the stems of in vitro elongated plants were subcultured in the same medium and kept in different light intensities (14, 41, and 50 μmol m−2 s−1) or continuous darkness. Another group of nodes was subcultured according to the position in the mother seedling. The plants
that showed the most stem elongation were those that were cultured in 14 μmol m−2 s−1 or that came from isolated nodal segments in the median and basal regions of the mother plant. After 2 mo, all of the plants
originating from the development of lateral buds were transferred to a greenhouse. Only those that were not elongated survived
ex vitro and flowered after 1 yr. 相似文献
20.
Mutalik S Manoj K Reddy MS Kushtagi P Usha AN Anju P Ranjith AK Udupa N 《AAPS PharmSciTech》2008,9(2):651-659
The purpose of this study was to develop a once daily sustained release tablet of aceclofenac using chitosan and an enteric
coating polymer (hydroxypropyl methylcellulose phthalate or cellulose acetate phthalate). Overall sustained release for 24 h
was achieved by preparing a double-layer tablet in which the immediate release layer was formulated for a prompt release of
the drug and the sustained release layer was designed to achieve a prolonged release of drug. The preformulation studies like
IR spectroscopic and differential scanning calorimetry showed the absence of drug–excipient interactions. The tablets were
found within the permissible limits for various physicochemical parameters. Scanning electron microscopy was used to visualize
the surface morphology of the tablets and to confirm drug release mechanisms. Good equivalence in the drug release profile
was observed when drug release pattern of the tablet containing chitosan and hydroxypropyl methylcellulose phthalate (M-7)
was compared with that of marketed tablet. The optimized tablets were stable at accelerated storage conditions for 6 months
with respect to drug content and physical appearance. The results of pharmacokinetic studies in human volunteers showed that
the optimized tablet (M-7) exhibited no difference in the in vivo drug release in comparison with marketed tablet. No significant difference between the values of pharmacokinetic parameters
of M-7 and marketed tablets was observed (p > 0.05; 95% confidence intervals). However the clinical studies in large scale and, long term and extensive stability studies
at different conditions are required to confirm these results. 相似文献