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.

scholarly journals Design Optimization and In Vitro-In Vivo Evaluation of Orally Dissolving Strips of Clobazam

2014 ◽  
Vol 2014 ◽  
pp. 1-15 ◽  
Author(s):  
Rajni Bala ◽  
Sushil Khanna ◽  
Pravin Pawar
Keyword(s):  
Tensile Strength ◽  
Drug Release ◽  
Content Uniformity ◽  
In Vivo Evaluation ◽  
Disintegration Time ◽  
Significant Difference ◽  
Film Formulation ◽  
Test Film

Clobazam orally dissolving strips were prepared by solvent casting method. A full 32 factorial design was applied for optimization using different concentration of film forming polymer and disintegrating agent as independent variable and disintegration time, % cumulative drug release, and tensile strength as dependent variable. In addition the prepared films were also evaluated for surface pH, folding endurance, and content uniformity. The optimized film formulation showing the maximum in vitro drug release, satisfactory in vitro disintegration time, and tensile strength was selected for bioavailability study and compared with a reference marketed product (frisium5 tablets) in rabbits. Formulation (F6) was selected by the Design-expert software which exhibited DT (24 sec), TS (2.85 N/cm2), and in vitro drug release (96.6%). Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product. The mean ratio values (test/reference) of Cmax (95.87%), tmax (71.42%), AUC0−t (98.125%), and AUC0−∞ (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles.

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 An Efficient Herbal Approach for Treating Fungal Infection in Cervical Cancer Patients by Developing and Optimizing a Vaginal Suppository

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Mohammed Ghazwani ◽  
Umme Hani ◽  
Riyaz Ali M. Osmani ◽  
Mohamed Rahamathulla ◽  
M. Yasmin Begum ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Side Effects ◽  
Drug Release ◽  
Cancer Patients ◽  
Poloxamer 407 ◽  
Vaginal Candidiasis ◽  
Disintegration Time ◽  
Drug Content ◽  
Vaginal Suppository ◽  
Weight Variation

Aim. The study is aimed at developing curcumin suppositories as a promising approach for natural antifungal management of vaginal candidiasis in cervical cancer patients to eradicate side effects produced by current antifungal drugs. The objective of the study was to optimize the suppositories using optimal (custom) design employing Design-Expert 13 software to recognize the concentration of polyethylene glycols (PEG) and Poloxamer 407 and obtain a stable suppository. Methodology. Combinations of PEG 1500 (10%–40%), PEG 6000 (40%–60%), and Poloxamer 407 (5%–30%) were entered as factors, and the responses evaluated were hardness, deformation time, and % drug release. In addition, the formulation was also evaluated for visual examination, weight variation, pH determination, drug content, hardness test, disintegration time, melting zone, deformation time, in vitro drug release, antifungal activity, and stability tests. Results. Suppositories were devoid of holes and cracks, with a characteristic odor and a dark yellowish-orange color. All formulations passed the weight variation test. Formulations exhibited pH ranging from 5.5 to 6.5. Drug content was observed to be 98.65 ± 0.041 % – 99.85 ± 0.041 % . The hardness of the formulation was between 2.9 and 4.2 kg/cm2. The disintegration time ranged from 11 ± 0.052   min to 20 ± 0.011   min . The melting point was between 41 ± 0 . 31 ° C and 58 ± 0 . 62 ° C . Deformation time ranged from 10 ± 0.45 to 35 ± 0.52   min . Most of the formulations resulted in 90% of drug release at 40 min, and the zone of inhibition noted was 19.6 ± 0.4   mm . All the selected factors have a significant effect on the response chosen for the study. Conclusion. The optimized curcumin vaginal suppository formulation can be an efficient herbal treatment devoid of side effects to treat vaginal candidiasis in cervical cancer patients.

scholarly journals ENHANCEMENT OF SOLUBILITY AND OPTIMIZATION OF ORALLY DISINTEGRATING FILMS OF ACYCLOVIR

2018 ◽  
Vol 11 (9) ◽  
pp. 280 ◽  
Author(s):  
Bikash Pandey ◽  
Arshad Bashir Khan
Keyword(s):  
Drug Release ◽  
Solid Dispersions ◽  
Hydroxypropyl Methylcellulose ◽  
In Vitro Release ◽  
Antiviral Agent ◽  
Disintegration Time ◽  
Casting Technique ◽  
Accelerated Stability ◽  
Full Factorial

Objective: The objective of this work was to prepare and optimize orally disintegrating films of acyclovir (ACV), which is a known antiviral agent. To enhance the solubility of ACV, solid dispersions of ACV were made.Methods: The films were prepared using a solvent casting technique. Full factorial design was utilized for the optimization of the effect of independent variables such as the amount of hydroxypropyl methylcellulose 5 cps, sodium starch glycolate, and propylene glycol on the disintegration time. Other evaluation tests such as drug release, drug content, thickness, and folding endurance of film were also conducted.Results: Compatibility studies by Fourier transform infrared showed that there was no significant interaction between the drug and excipients used. Disintegration time was found to be 43 s for the optimized batch. The in vitro release profile of formulation response disintegrating time in phosphate buffer pH 6.8 revealed that there was a significant increment in drug release of the optimized batch in comparison to the screening batches. Further, short-term accelerated stability studies carried out for 4 weeks for the optimized formulation which proved that the formulated films were stable at the accelerated conditions of temperature and humidity (40±2°C/75±5% RH).Conclusions: It was concluded that such ACV solid dispersion films could be beneficial in enhancement of dissolution and consequently the oral bioavailability of ACV.

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 THE DEVELOPMENT AND CHARACTERISATION OF FAST DISSOLVING FILM OF POORLY WATERSOLUBLE DRUG LURASIDONE HYDROCHLORIDE

2021 ◽  
pp. 170-177
Author(s):  
ANAGHA PRABHU ◽  
ASMITA ARONDEKAR Arondeka ◽  
PRASHANT BHIDE ◽  
SHWETA BORKAR
Keyword(s):  
Drug Release ◽  
Hydroxypropyl Methylcellulose ◽  
Onset Of Action ◽  
Disintegration Time ◽  
In Vitro Drug Release ◽  
Casting Technique ◽  
Drug Content ◽  
In Vitro Disintegration ◽  
Lurasidone Hydrochloride

Objective: The objective of the present work was to formulate and evaluate a fast-dissolving oral film of lurasidone hydrochlorideused as an atypical antipsychotic for the treatment of schizophrenia capable of providing faster onset of action. Methods: The fastdissolving films of lurasidone hydrochloride were prepared by the solvent casting technique using different compositions and combinations of hydroxypropyl methylcellulose E-3, E-5, E-15, and K4M as fast-dissolving polymer bases. A set of seven formulations were prepared and evaluated for parameters like physical characterization, thickness, weight uniformity, mechanical characteristics (folding endurance,tensile strength), surface pH, in vitro disintegration time, drug content, and an in vitro drug release. Results: The prepared films exhibited uniform and a smooth surface with uniform weight, thicknessand 89-90% mg drug content. The formulation F7 Showed excellent elasticity and disintegration within seconds. Lurasidone hydrochloride was rapidly released in vitro from all formulations. The release was found to be rapid and maximum of 41.5% in Phosphate buffer pH 6.8 and 58.6% in 0.1 N hydrochloric acid over a period of 30 min. The further optimized formulation F7Adepicted a faster and maximum release of 78% as compared to the marketed tablet 74%. Conclusion: The developed formulation is a better alternative to tablets by its ability to produce good drug release.

scholarly journals Application of Central Composite Design for Citalopram Hydrogen bromide Mouth Dissolving Films

2020 ◽  
pp. 360-367
Author(s):  
Shimmula Rohini Reddy ◽  
Bomma Ramesh
Keyword(s):  
Tensile Strength ◽  
Drug Release ◽  
Central Composite Design ◽  
Hydrogen Bromide ◽  
Drug Dissolution ◽  
Effective Dosage ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Disintegration Time ◽  
Central Composite

Citalopram is an antidepressant used for treating major depressive disorder. In the current work Citalopram HBr is formulated as mouth dissolving film with enhanced drug dissolution. The Central Composite Design (CCD), employed to examine the effects of amount of HPMC E50 (A), amount of maltodextrin (B) and amount of glycerol (C) on response variables tensile strength, disintegration time and cumulative % drug release. 27 formulations prepared according to CCD and evaluated for physicochemical parameters and in vitro dissolution studies. Citalopram HBr mouth dissolving films formulated by employing solvent-casting method using HPMC E50, maltodextrin and glycerol, optimized for the effective dosage of superdisintegrants.  The formulation CF21 with maximum tensile strength of 67.21±1.31 gm, least disintegration time of 9±1.60 sec and highest drug release of 98.41±1.81% is chosen optimal formulation with maximum content uniformity and folding endurance. It is evident from the above results that the developed formulation can be an innovative dosage form to improve the drug delivery, quick onset of action as well as improve patient compliance in the effective management of depression.

scholarly journals FORMULATION AND EVALUATION OF CILNIDIPINE MUCOADHESIVE BUCCAL FILM BY SOLVENT CASTING TECHNIQUE FOR THE TREATMENT OF HYPERTENSION

2021 ◽  
pp. 34-43
Author(s):  
SHIFA SHAUKAT HAJU ◽  
SHEELA YADAV
Keyword(s):  
Tensile Strength ◽  
Drug Release ◽  
Calcium Channel ◽  
Content Uniformity ◽  
Solvent Casting ◽  
Casting Technique ◽  
Drug Content ◽  
Buccal Drug Delivery ◽  
Folding Endurance

Objective: Buccal drug delivery is the most suited route for local as well as systemic delivery of drugs. Cilnidipine is an L/N type dihydropyridine 4th generation calcium channel blocker (CCB), which decreases hypertension by blocking the N-type calcium channel to attenuate vascular sympathetic neurotransmission. It has high first-pass metabolism leading to low bioavailability. Hence the present research work was undertaken to formulate mucoadhesive buccal film of Cilnidipine with an objective to enhance therapeutic efficacy, bioavailability and was developed to administer into the unconscious and less-co-operative patients. Methods: Cilnidipine buccal films were prepared by a solvent-casting technique using various concentrations of mucoadhesive-polymers such as Hydroxyl propyl methylcellulose (HPMC) E15 and K4M and ethyl-cellulose as backing-layer, which acts like a patch providing unidirectional drug release. Prepared films were evaluated for their weight variation, thickness, surface-pH, swelling-index, drug content uniformity, in vitro residence time, folding endurance, tensile strength, in vitro release and permeability studies. Results: The infra-red (IR) spectra showed no interaction, and Physico-chemical characteristics were found within the limit. Swelling of the film increases with increasing concentration of polymers and %drug content of all formulations found to be in the range of 92.13%±0.94% to 97.92%±0.35%. The formulation F5, showed a promising tensile strength, folding endurance and in vitro drug release of about 95.18±0.03%, thus can be selected as an optimized formulation of mucoadhesive buccal film. Conclusion: The formulation of Cilnidipine mucoadhesive buccal film was found to be satisfactory and reasonable.

scholarly journals Mouth Dissolving Film of Domperidone: An approach towards Formulation and its Evaluation

2021 ◽  
pp. 140-150
Author(s):  
Khanderao Jadhav ◽  
Shivraj Jadhav ◽  
Deepak Sonawane ◽  
Deepak Somvanshi ◽  
Hina Shah ◽  
...  
Keyword(s):  
Tensile Strength ◽  
Drug Release ◽  
Stability Study ◽  
Preparation Technique ◽  
In Vivo Evaluation ◽  
Casting Technique ◽  
Dsc Studies ◽  
Oral Films

The objective of the current work is to formulate and evaluate the mouth dissolving film of domperidone. It is ideally suitable for the treatment of emesis. The mouth dissolving film of domperidone is useful in the vomiting through the journey. Mouth dissolving films were formulated by the solvent casting technique and its in-vitro as well as the in-vivo evaluation was done by the usual pharmacopoeial and unofficial tests and by using human volunteers. The main benefit of the preparation technique includes fewer operation units, better content consistency. The mouth dissolving film formed was found to be disintegrated in 1 minute. The ratio of components in the aqueous phase affected the thickness, drug content, tensile strength, percentage elongation, folding endurance, and release profile of mouth dissolving film and the best results were obtained for the HPMC E15 and polyethyleneglycol. The compatibility between domperidone and excipients was confirmed by FTIR and DSC studies. The developed mouth dissolving film of domperidone demonstrated usefulness for fast release of drug in mouth, for better drug utilization, and improved patient compliance. The optimized formulation, due to low HPMC E15 content, has optimum tensile strength and thickness. Formulation F8 containing HPMC E15 and PG showed a cumulative % drug release of 95.10 at the end of 12 minutes. HPMC E15 films showed higher cumulative % drug release than films of other HPMC E grades at different concentrations. It was found to be stable during the accelerated stability study. The effect of different concentrations of polymers and plasticizers on in-vitro evaluation parameters was evaluated. Hence, data showed that formulation F8 was the most suitable for the development of fast dissolving oral films of domperidone.

scholarly journals Design and Development of Fast Dissolving Thin Films of Losartan Potassium

2016 ◽  
Vol 8 (01) ◽  
Author(s):  
N. G. Raghavendra Rao ◽  
C. Kistayya ◽  
Gampa Kumar
Keyword(s):  
Research Work ◽  
Losartan Potassium ◽  
Content Uniformity ◽  
Disintegration Time ◽  
Casting Technique ◽  
Rapid Action ◽  
Film Forming ◽  
Film Formulation ◽  
In Vitro Disintegration

The purpose of this research work was to formulate a fast dissolving film of Losartan potassium for the treatment of hypertension. The fast dissolving films of Losartan potassium were prepared by solvent casting technique using film forming polymer HPMC 15 and 50 cps and PEG is used as plasticizer. From the preliminary physical observation of these prepared films the best were selected for incorporation of Losartan potassium. The electron microscopy showed that the films are clear, colorless with smooth surface and little pores, without any scratches on the films. All the films prepared were evaluated for Physical appearance and surface texture, weight uniformity of films, thickness of the films, folding endurance, surface pH, drug content uniformity and in-vitro disintegration time of films all the results were found to be satisfactory. The t50% and t90% values decreased with increase in the concentration of SSG, CCS and CP. The rapid increase in dissolution of Losartan potassium with the increase in CCS. Among all the film formulation FA2 and FA8 (6% CCS HPMC 15 and 50 cps) were found to be promising and showed a disintegration time of 36 and 32 sec, respectively and 50% of drug released in 9.74 and 8.19 min, and 90% of drug released in 18.00 and 17.12 min respectively. Based on the above results it can be concluded that the fast dissolving oral film of Losartan potassium may produce the rapid action thereby enhance the absorption by avoiding the first pass effect.

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