release study
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Author(s):  
MAZIN THAMIR ABDUL-HASAN ◽  
ABULFADHEL JABER NEAMAH Al-SHAIBANI ◽  
ALI N. WANNAS ◽  
KARRAR MOHAMMED HASAN AL-GBURI

Objective: This study was employed to evaluate the quality of marketed oral tablets containing clopidogrel bisulfate. Tablets produced by various companies and commercialized in the Iraq market were used in the study. Methods: Batches of clopidogrel bisulfate conventional tablets (containing 75 mg of drug) were exposed to the quality control tests. These tests involved friability, weight variation, hardness, drug content, disintegration time, and in vitro release study; these tests were conducted depending on USP pharmacopeia. Results: The data indicate that all batches of clopidogrel bisulfate complied with the limitations of USP pharmacopeia for variation of weight, results of the hardness of tablets were 7.2-9.6 Kg/cm2. Friability value (% loss) was less than one, which was within the required limits. The time of disintegration was less than 25 min in both artificial gastric fluid (AGF) and artificial intestinal fluid (AIF). Drug content was observed between 97.1 % and 99.8 %, indicating compliance with the limits of pharmacopeia (85-115 %). An in vitro release study of batches was greater than 80 % within 25 min. Conclusion: All batches of clopidogrel bisulfate were manufactured within the criteria of tablet manufacturing. The quality control tests of tablets showed acceptable pharmaceutical properties (effectiveness and safety) that lie within the limits of USP pharmacopeia.


2021 ◽  
Vol 11 ◽  
Author(s):  
Vaibhav Rajoriya ◽  
Varsha Kashaw ◽  
Sushil Kumar Kashaw

Objective: The current paper represents the development, optimization, and characterization of paclitaxel-loaded folate conjugated solid lipid nanoparticles (FA-SLNs). Methods: The ligand (FA-SLNs) conjugated and non-conjugated SLNs (PTX-SLNs) were prepared by hot homogenization method. Both of the formulations (FA-SLNs and PTX-SLNs) were optimized with various parameters i.e. drug loading, stirring time, stirring speed, particle size, and polydispersity index, and characterized. The in-vitro drug release study was performed in different pH environments by using the dialysis bag method. The surface morphology and particle size were determined through scanning electron micorscopy and Transmission Electron Microscopy respectively, The SLNs formulations were also evaluated for the stability study. Result: The particle size of PTX-SLNs and FA-SLNs was determined and found to be 190.1±1.9 and 231.3±2.3 nm respectively. The surface morphology of the SLNs indicates that the prepared formulations are round-shaped and show smooth surfaces. The TEM study indicated that particles were in the range of 100-300 nm. The entrapment efficiency and drug loading capacity of FA-SLNs were found to be 79.42±1.6% and 17.3±1.9%, respectively. In-vitro drug release study data, stated that the optimum drug release was found in an acidic environment at pH 4.0, that showed 94.21% drug release after 16 hours and it proves that optimized formulation FA-SLNs will gave the sustained and better release in tumor tissue that owing acidic environment because of the angiogenesis process. Conclusion: In this research paper, different formulation parameters, found to influence fabrication of drug into Solid lipid nanoparticles, were optimized for high entrapment efficiency and drug loading. The most important parameters were drug:lipid ratio, drug:polymer ratio and lipid: surfactant ratio. Higher in-vitro drug release was observed in pH 4 as compared to the pH 7.4. These result data concludes that FA-SLNs formulation was successfully prepared, optimized and characterized.


Heliyon ◽  
2021 ◽  
pp. e08674
Author(s):  
Yedi Herdiana ◽  
Nasrul Wathoni ◽  
Shaharum Shamsuddin ◽  
Muchtaridi Muchtaridi

Author(s):  
Shruti Rathore ◽  
Alpana Ram ◽  
Dipesh Lall ◽  
Bhagyashree Agrawal ◽  
Pranay Soni ◽  
...  

In present work, sunscreen cream containing Benzophenone – 3 microspheres were prepared and an attempt were made to deliver sunscreening agent in sustained release manner from microspheres containing cream. Microspheres are prepared by emulsion cum thermal gelation technique and the o/w emulsion was selected as cream. Optimized batch of microspheres were taken and mixed with cream. This cream was subjected to determination of various parameters like color, pH, rancidity, viscosity, spreadability and extrudability. In vitro drug release study and SPF were determined. Cream has also been evaluated for in vivo ocular toxicity testing, skin irritancy testing, testing for sensitizing potential, and photosensitivity test. Results revealed that no ocular irritation and skin irritation occurs. Physical stability and chemical stability were tested. Sunscreen cream is homogeneous, smooth on application, having good spreadability and extrudability and milky white in color. The pH was found to be 7.1. Cream shows viscosity 32840 cps, no rancidity and no phase separation on centrifugation were observed. In vitro drug release study revealed that both 1% and 2% microspheres containing cream follow zero order release kinetics which means release rate was found constant. In vitro SPF was evaluated mean SPF of 1% cream was 13.74 and mean SPF of 2% cream was 31.47. Physical stability testing revealed that cream was not greatly affected by various stress conditions like freeze-thaw (-5 to +5°C), shaking (100-500 rpm) and centrifugation (1000-5000 rpm) except 5000 rpm. Results of chemical stability revealed that the formulations exhibited good stability at elevated temperature between 25-45°C and slight changes may occur which are reversible in nature. In present work attempt were made to develop microspheres containing sunscreen cream and it was characterized for various parameters. Sunscreen cream was safe and effective and also showed sustain drug release.


Author(s):  
Koushlesh Kumar Mishra

Objective: The objective of the present work was to develop, optimize and characterize itraconazole loaded transethosomes for enhanced transdermal delivery. In this study, screening of formulation and process variables was conducted by using Box-Behnken design approach to observe significant and insignificant influence on the transethosomes. Methods: The transethosomes was developed by homogenization technique (hot method). The optimized itraconazole loaded transethosomes were evaluated for its vesicle size, polydispersity index, zeta potential, loading capacity and entrapment efficiency. Characterization was done by P-XRD, DSC and TEM. Further, in-vitro drug release study, stability study and confocal laser scanning microscopy (CLSM) study were also performed. Results: The itraconazole loaded transethosomes are developed by using soya lecithin as phospholipid, oleic acid as edge activator and cholesterol as stabilizer. Developed transethosomes showed acceptable desired vesicle size (207-409 nm), excellent colloidal dispersion characteristics (polydispersity index- 0.131 to 0.312, zeta potential -16.12to -21.96 mV) and high drug entrapment (63.37-73.02%). P-XRD and DSC results suggested that itraconazole encapsulated in amorphous state within transethosomes. In-vitro drug release study show prolonged release of itraconazole for 24 hr and confocal laser scanning microscopy confirmed accumulation of transethosomes in deeper layers of the skin. Results of stability studies showed optimized transethosomes are more stable in refrigerated temperature (4°C) as compared to room temperature (25°C). Conclusion: The results suggested that transethosomes could be better alternative to deliver drugs across the skin and potential carrier for efficient transdermal drug delivery.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ripunjoy Bordoloi ◽  
Abdul Baquee Ahmed ◽  
Kunal Bhattacharya

Abstract Background The current study was carried out to evaluate the possible application of Musa balbisiana starch in formulation of mucoadhesive microsphere for oral delivery of gliclazide (GLZ). The study objective was to improve the oral bioavailability along with prolongation of its duration of action for a better glycaemic control. Ionic gelation technique was employed in formulating the dosage form. Optimization of the batches was carried out by response surface methodology using 32 full factorial designs. The microsphere prepared was characterized for several parameters along with its in vitro release study. The gastrointestinal transit of the optimized batch of prepared microspheres after oral administration was studied in rabbits by using the gamma scintigraphy technique utilizing 99mTc as the labelling agent in the presence of stannous chloride. Also, the optimized batch was studied for its pharmacokinetic parameters. Moreover, the antidiabetic efficacy of the prepared microsphere was evaluated in rats by using the streptozotocin (STZ)-induced diabetic model. Results The factorial design experiment resulted in an optimum formulation coded as F8. The compatible nature of the drug and excipient was revealed from FTIR, DSC and IST studies. The scanning electron micrographs also showed the occurrence of spherical microspheres having a smooth surface. The in vitro release study provided an evidence of an initial burst effect that was followed by a prolong release phase. The pharmacokinetic parameters justified the ability of the prepared dosage form in sustaining the drug release with a 2.7-fold enhancement in drug bioavailability. The images obtained during the gamma scintigraphy study suggested the gastro-retentive nature of the dosage form with the gastro-retentive ability for more than 4 h. Also, the pharmacodynamics study carried out in diabetic rat model confirmed about the better efficacy of the dosage form in lowering the elevated blood glucose level. Conclusion The overall study data provide valuable information about the potential of this banana starch in formulation of a mucoadhesive dosage form that can be used for enhancement of bioavailability of drug-like gliclazide which in turn can provide a beneficial effect in the management of diabetes.


Author(s):  
ANJU PARAMBIL ◽  
SEENIVASAN PALANICHAMY ◽  
ARUL KUTTALINGAM ◽  
VELLAPANDIAN CHITRA

Objective: The purpose of the present study was to formulate and evaluate the polymeric transdermal delivery system of antipsychotic drug Trifluoperazine (TFP) for sustained drug release. Methods: A transdermal patch loaded with (TFP) was formulated by solvent casting technique. Polyvinyl pyrrolidone (PVP) K-30 and ethyl cellulose (EC) was used as a polymeric matrix with different ratios. Di n-butyl phthalate was used as a plasticizer. The parameters such as thickness, folding endurance and weight variation of the prepared patches were studied. The interaction study by attenuated total reflectance-infrared (ATR-IR) spectroscopy, X-ray diffraction and thermal analysis by differential scanning calorimetry (DSC) were performed. In vitro drug release study was performed by modified paddle over-disc technique. Results: The infrared spectroscopic study confirmed the absence of any chemical interaction between TFP and selected polymers. All the prepared formulations showed folding endurance values ranging from 130-162 and a satisfactory drug loading of 90-95%. In in vitro drug release study, formulations PE-3 and PE-4 exhibited a sustained and stable cumulative release of 54 % and 48% respectively, at the end of 24 h. The DSC and XRD analysis proved the partial conversion of the drug from crystalline to amorphous form when integrated into the polymeric matrix. Conclusion: The prepared transdermal formulations using polymers PVP and ethyl cellulose demonstrated their ability to sustain the release of TFP. The developed formulation could be exploited for multiday therapy of TFP for the effective treatment of schizophrenia with a simplified dosing regimen and enhanced patient compliance.


2021 ◽  
pp. 101171
Author(s):  
Farrokh Alemi ◽  
Hua Min ◽  
Melanie Yousefi ◽  
Laura K Becker ◽  
Christopher A Hane ◽  
...  
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