scholarly journals DESIGN AND STATISTICAL OPTIMIZATION OF MOUTH DISSOLVING SUBLINGUAL FILM OF FIXED DOSE COMBINATION OF DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE USING DESIGN OF EXPERIMENT IN THE TREATMENT OF NAUSEA AND VOMITING IN PREGNANCY

2018 ◽  
Vol 11 (12) ◽  
pp. 202
Author(s):  
Bobde Suwarna Suresh ◽  
Tank Hemraj M
Keyword(s):  
Tensile Strength ◽  
Drug Release ◽  
Nausea And Vomiting ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Pyridoxine Hydrochloride ◽  
Onset Of Action ◽  
Disintegration Time ◽  
Folding Endurance ◽  
Dose Combination

Objective: The present research aims at formulating a mouth dissolving sublingual film of fixed dose combination of doxylamine succinate (DS) and pyridoxine hydrochloride (PH) that would provide faster onset of action and hence relief from the condition of nausea and vomiting in pregnancy.Methods: Mouth dissolving films were prepared using a solvent casting technique. A 23 full-factorial design of eight formulations was set up with three independent variables: X1 - polymer 1 HPMC E15 concentration, X2 - polymer 2 HPMC E5 concentration, and X3 - plasticizer PEG 400 concentration. The responses, i.e., dependent variables measured for the study were Y1 disintegration time in seconds, Y2 tensile strength in kg/cm2, Y3 drug release in the percentage of DS, and Y4 drug release in the percentage of PH. All the formulations were evaluated for physicochemical parameters such as clarity, weight, thickness, folding endurance, surface pH, and content. The design expert software 11.0 trial version was used for statistical analysis of the responses.Results and Conclusion: All the film formulations were found to be transparent, non-tacky, and easily peelable having the satisfactory tensile strength and folding endurance. The concentration of polymer 1 and 2 was found to have a significant effect on disintegration time and drug release of mouth dissolving films. The best film formulation DP1 was found to have a disintegration time of 77.66 s and found to release 96.22% of DS and 95.43% of pyridoxine HCl in 21 min.

scholarly journals FORMULATION AND EVALUATION OF CHLOROTHALIDONE LOADED MOUTH DISSOLVING FILM-A BIOAVAILABILITY ENHANCEMENT APPROACH USING MULTILEVEL CATEGORIC DESIGN

2020 ◽  
pp. 34-41
Author(s):  
SHUBHAM BIYANI ◽  
SARANG MALGIRWAR ◽  
RAJESHWAR KSHIRSAGAR ◽  
SAGAR KOTHAWADE
Keyword(s):  
Drug Release ◽  
Hydroxypropyl Methylcellulose ◽  
Aqueous Dispersion ◽  
Onset Of Action ◽  
Polyethylene Glycol 400 ◽  
Bioavailability Enhancement ◽  
Disintegration Time ◽  
Peg 400 ◽  
Folding Endurance

Objective: The intension of the present study includes fabrication and optimization of mouth dissolving film loaded with Chlorothalidone by solvent evaporation techniques using two components and their three levels as multilevel Categoric design. Methods: Major problem associated with the development of film loaded with BCS class II drug is to increase its solubility. Here the Chlorothalidone solubility achieved by co-solvents, such as methanol. After dissolving the drug in co-solvent, this drug solution is poured into an aqueous dispersion of Hydroxypropyl Methylcellulose E5 (HPMC E5) and Polyethylene glycol 400 (PEG 400). The two independent variables selected are factor A (concentration of HPMC E5) and factor B (concentration of PEG 400) was selected on the basis of preliminary trials. The percentage drug release (R1), Disintegration time in sec (R2) and folding endurance (R3) were selected as dependent variables. Here HPMC E5 used as a film former, PEG 400 as plasticizer, mannitol as bulking agent, Sodium starch glycolate as a disintegrating agent, tween 80 as the surfactant, tartaric acid as saliva stimulating agent, sodium saccharin as a sweetener and orange flavour etc. These fabricated films were evaluated for physicochemical properties, disintegration time and In vitro drug release study. Results: The formulation F6 has more favorable responses as per multilevel categoric design is % drug release about 98.95 %, average disintegration time about 24.33 second and folding endurance is 117. Thus formulation F6 was preferred as an optimized formulation. Conclusion: The present formulation delivers medicament accurately with good therapeutic efficiency by oral administration, this mouth dissolving films having a rapid onset of action than conventional tablet formulations.

scholarly journals DESIGN, CHARACTERIZATION AND STATISTICAL OPTIMIZATION OF RAMOSETRON HYDROCHLORIDE MOUTH DISSOLVING FILM USING DESIGN OF EXPERIMENT

2019 ◽  
pp. 224-230
Author(s):  
SUWARNA SURESH BOBDE ◽  
HEMRAJ M. TANK
Keyword(s):  
Tensile Strength ◽  
Drug Release ◽  
Cancer Patients ◽  
Nausea And Vomiting ◽  
Disintegration Time ◽  
Percent Elongation ◽  
Casting Technique ◽  
Factor Design ◽  
Film Formulation ◽  
Formulation Variables

Objective: The present study aims to prepare a mouth dissolving film of ramosetron hydrochloride to provide relief to cancer patients suffering from nausea and vomiting. Methods: Mouth dissolving film of ramosetron hydrochloride were prepared and optimized using three levels two factor design. The films were prepared using the solvent casting technique. The effect of formulation variables such as the concentration of HPMC E15, and honey on disintegration time, tensile strength and drug release from the film were studied. The films were evaluated for weight, thickness, folding endurance, tensile strength, percent elongation, surface pH, disintegration time and drug release. Results: All the films were found to be transparent, non-sticky and easily peelable. The concentration of HPMC E 15 and Honey was found to have a significant effect on disintegration time and drug release of the mouth dissolving film. Formulation R1 was found to the best formulation with 104.21 % release in 9 min and disintegration time of 57 seconds. Conclusion: It can be concluded that the developed mouth dissolving film could serve as an effective, convenient alternative to prevent nausea and vomiting in cancer patients of any age group.

The fixed-dose combination of tiotropium + olodaterol has a rapid onset of action in patients with COPD

2015 ◽  
Author(s):  
Gary T. Ferguson ◽  
Emilio Pizzichini ◽  
Matjaz Flezar ◽  
Lars Grönke ◽  
Lawrence Korducki
Keyword(s):  
Rapid Onset ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Onset Of Action ◽  
Dose Combination

scholarly journals FORMULATION, OPTIMIZATIONANDEVALUATION OF SUBLINGUAL FILM OF ENALAPRILMALEATE USING 32 FULL FACTORIAL DESIGN

2021 ◽  
pp. 178-186
Author(s):  
SATYAJIT SAHOO ◽  
KIRTI MALVIYA ◽  
AMI MAKWANA ◽  
PRASANTA KUMAR MOHAPATRA ◽  
ASITRANJAN SAHU
Keyword(s):  
Tensile Strength ◽  
Drug Release ◽  
Factorial Design ◽  
Full Factorial Design ◽  
Disintegration Time ◽  
Surface Ph ◽  
Independent Variables ◽  
Folding Endurance ◽  
Full Factorial ◽  
32 Full Factorial Design

Objective: The purpose of this investigation was to formulate, optimize and evaluate sublingual film of Enalapril maleate for rapid management of Hypertension. Methods: Sublingual films were prepared by solvent casting method. Present investigation were formulated by using HPMC E 15 (X1) as polymer and Polyethylene glycol (X2) as plasticizer were chosen as independent variables in 32 full factorial design while Tensile strength (TS), Disintegration time (DT) and % Cumulative drug release at 10 min. (% CDR) were taken as dependent variables. The various physical parameters were evaluated for sublingual films such as thickness, tensile strength, folding endurance, disintegration time, surface pH and % CDR. Results: From the experimental study, it was concluded that the optimized batch F8 showed 98.6 %, the highest release of the drug. Stability study was performed by taking an optimized formulation and it was observed stable. The sublingual films showed acceptable results in all studies such as thickness, tensile strength, folding endurance, disintegration time, surface pH and % CDR at 10 min. R2 values for Tensile Strength (Y1), Disintegration time (Y2) and % cumulative drug release at 10 min. of Enalaprilmaleate(Y3) found to be 0.9852, 0.9829 and 0.9641 respectively. Thus, a good correlation between dependent and independent variables was developed. Conclusion: 32 full factorial design was successfully applied during preparation, optimization and evaluation of sublingual films of Enalapril maleate. The present investigation showed quick disintegration and fast release of the drug for rapid management of Hypertension.

scholarly journals Formulation and Optimization of Monolithic Fixed-Dose Combination of Metformin HCl and Glibenclamide Orodispersible Tablets

2020 ◽  
Vol 2020 ◽  
pp. 1-14
Author(s):  
Anteneh Belayneh ◽  
Fantahun Molla ◽  
Getu Kahsay
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Pill Burden ◽  
Compression Force ◽  
Disintegration Time ◽  
Peg 6000 ◽  
Ir Studies ◽  
Orodispersible Tablets ◽  
Swallowing Problems ◽  
Dose Combination

The treatment of type II DM involves the use of combination of drugs, especially at the chronic stage. However, the pill burden of this combination therapy combined with swallowing difficulties, occurring at a later stage of DM, has been the major challenge for successful treatment outcomes. This study was aimed at formulating and optimizing a monolithic fixed-dose combination (FDC) of metformin (MET) and glibenclamide (GLB) orodispersible tablets (ODTs) to overcome both the pill burden and swallowing problems. The FDC ODTs were prepared by the melt granulation technique using polyethylene glycol (PEG) 6000 as a binding agent and crospovidone as a superdisintegrant. In the preliminary study, the effects of sodium lauryl sulphate (SLS), PEG 6000, crospovidone, and compression force on friability, disintegration time, and drug release of tablets were investigated. The FT-IR studies showed that there were no incompatibilities between MET and GLB as well as within excipients. The preliminary studies revealed that PEG 6000 and compression force significantly affect both the friability and the disintegration time, while SLS and crospovidone only affect the disintegration time. Therefore, the effects of PEG 6000, crospovidone, and compression force were further studied and optimized using the central composite design. Accordingly, the most desirable optimal values were obtained at 3.82% of PEG 6000, 9.83% of crospovidone, and 10.6 kN compression force having a friability of 0.302% and a disintegration time of 18.7 seconds. From these results, it can be concluded that a monolithic FDC of MET and GLB ODTs having adequate mechanical strength and faster disintegration time was successfully formulated.

scholarly journals Formulation and Evaluation of Fixed Dose Combination Suppositories Containing Stavudine, Lamivudine and Nevirapine for Pediatric Applications

2015 ◽  
Vol 7 (3) ◽  
pp. 87-96 ◽  
Author(s):  
Y. Padmavathi ◽  
B. M. Reddy ◽  
M. Renuka ◽  
K. Sumedha ◽  
N. P. Reddy
Keyword(s):  
Drug Release ◽  
Pediatric Hiv ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Physical Parameters ◽  
New Era ◽  
Weight Variation ◽  
Suppository Base ◽  
Dose Combination ◽  
Living With Hiv

Suppositories are the convenient way of administering drugs in infants. In view of the lack of suitable pediatric antiretroviral formulations in the market, suppositories containing fixed dose combination (FDC) of stavudine, lamivudine and nevirapine (SLN) were developed to allow administration of the correct weight-related dose in pediatric HIV patients as recommended by WHO. Suppositories containing 10 mg of stavudine, 40 mg of lamivudine and 70 mg of nevirapine were prepared by the fusion method using Witepsol H15 semi-synthetic suppository base. All the prepared suppositories were evaluated for various physical parameters like weight variation, melting point, drug content and hardness. The rate and extent of drug release was evaluated using USP apparatus I and samples were analyzed by a validated UV-multicomponent method. The use of surfactants significantly increased the drug release from formulations manufactured with Witepsol H 15 fatty base. The development of pediatric fixed-dose combination formulations represent a new era and mark an important milestone for children living with HIV/AIDS.

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