Objective: The aim of the present work was to enhance the solubility of rosuvastatin calcium by self-nano emulsifying drug delivery system (SNEDDS) using mixtures of oil, cosolvent, surfactant and cosurfactant. Methods: Based on solubility study and emulsification efficiency, Preliminary investigations of various oils, surfactants and cosurfactants were carried out for the selection of the proper SNEDDS ingredients. Pseudo-ternary phase diagrams were constructed to identify the efficient self-emulsification region. A series of SNEDDS formulations were prepared using labrasol: cremophor EL with a combination of peceol: ethyl oleate by using the simplex lattice design. Prepared formulation evaluated for refractive index, turbidimetric, droplet size, zeta potential and polydispersity index, self-emulsification, stability tests, viscosity and in vitro diffusion studies. Results: The best formula for SNEDDS in the current study were: 15% oil (peceol: ethyloleatein 1:1 ratio), 50% Labrasol and 35% Cremophor EL. All the SNEDDS batches globule size was found to be varied from 22.90±1.50 nm to 43.90±1.40 nm. and no significant variations in globule size were observed after 3 mo stability studies. All the batches % transparency was found to be varied from 95.40±1.40% to 99.50±1.10% and drug diffused in 10 min varied from 63.65±1.51% to 93.72±1.46 %. Conclusion: The data suggest the use of rosuvastatin calcium SNEDDS to offer the potential for delivery and it increases the aqueous solubility and bioavailability of the drug.
Objective: The aim of present work was to develop of pediatric cefuroxime axetil 125 mg dispersible tablets by using ion exchange resin as a taste masking agent and quality target product profile was defined based on the properties of the cefuroxime axetil. Methods: Initially, cefuroxime axetil and various resin complexes (DRC) were prepared with different conditions and evaluated for taste masking and drug loading. Optimized DRC was used to formulate the dispersible tablet. A 32 full factorial design was employed to study the effect of mannitol (X1) and microcrystalline cellulose PH-101 (X2) on drug release at 10 min and time taken to 80% drug release. In the present study, the following constraints were arbitrarily used for the selection of an optimized batch: Q10>65% and T80%<30 min. Multiple linear regression analysis, ANOVA and graphical representation of the influence factor by 3D plots were performed by using Sigmaplot 11.0. Checkpoint batch was prepared to validate the evolved model. Results: Among the various drug resins complex DRC-9 was found with less bitter taste which was containing kyron T-114 and among the all factorial batch F7 showed highest drug release at 10 min (Q10) and lowest time taken to 80% drug release (T80) hence batch F7 was selected as an optimized batch and it’s found to be stable in the stability evaluation. Conclusion: The results of full factorial design indicate mannitol and MCC PH-101 have a significant effect on drug release.
Objective: Aim of the present study was the optimization of the sustained release (SR) layer of isosorbide dinitrate (ISDN) 40 mg and compressed with the immediate-release (IR) layer of hydralazine hydrochloride (HHC) 25 mg to decrease the dosing frequency and development of a novel b. i. d dosage form. Methods: Drug excipients compatibility study was carried out by FT-IR and a preliminary study was conducted for screening of polymer. The amount of HPMC K100M (X1) and the amount of Polyoxtm WSR303 (X2) were chosen as independent variables in 32full factorial designs. While % cumulative drug releases at 1 h (Q1) (Y1), % cumulative drug release at 2 h (Q2) (Y2), % cumulative drug release at 4 h (Q4) (Y3) and % cumulative drug release at 6 h (Q6) (Y4), were taken as dependent variables and statistically evaluation by using sigma plot 13.0. In the present study, according to the U. S. P. 2007 the following constraints were used for the selection of an optimized batch: Q1=15% to 30%, Q2=50% to 70%, Q4=65% to 85% and Q6>75%. To validate the evolved mathematical models, a checkpoint batch was selected from its desirability value. Results: FT-IR spectra show that the drug and excipients were compatible with each other. The calculated F values found for Q1, Q2, Q4, and Q6 were 084.583, 038.188, 057.719, and 118.396, respectively. All Calculated F values are greater than the tabulated value for all dependent variables. Prepared checkpoint batch selected from its desirability value 1 and it gives a 93.40±1.29 % drug release within 6 h. Conclusion: This bilayer formulation of anti-hypertensive drugs decreases the dosing frequency of HHC and ISDN.
Objective: The aim of the present work was to prepare film coated tablet of glucosamine sulfate potassium chloride and study the effect of coating process parameters which implicate more significant effects on an aqueous-based film coating process of tablets. Methods: The different batches of uncoated tablets were prepared by wet granulation method. Aqueous film coating was carried out by using opadry®II white 85F18422. A 32 full factorial design was employed to study the effect of spray rate (X1) and inlet air temperature (X2) on coating uniformity, coating process efficiency and % loss on drying. The surface characteristics of the aqueous based film coated tablet were studied using a SEM. Check point batch was prepared to validate the evolved model. Results: Preliminary trials indicated that individually process parameters affected the quality of coated tablets. Hence, studied the combined effect of these factors on the coating process required and 32 full factorial design was applied. In this study, it was seen that spray rate and inlet air temperature had a major effect on tablet coating process. It was observed from factorial batch that maximum drug release was found in batch F5. Conclusion: The results of full factorial design indicate both parameters spray rate (X1) and inlet air temperature (X2) have significant effect on coating process and batch F5 is stable for 3 mo at accelerated condition.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.