FORMULATION AND EVALUATION OF FAST DISSOLVING FILM OF FOSINOPRIL

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (12) ◽  
pp. 34-40
Author(s):  
V.V Pande ◽  
◽  
A.A. Patel ◽  
V.P. Patel ◽  
P.V. Khedkar

The mouth dissolving film overcomes the shortfalls of conventional quick dispersing/dissolving intraoral tablets. Fosinopril is an angiotensin converting enzyme (ACE) inhibitor used for the treatment of hypertension and some types of chronic heart failure.It undergoes extensive hepatic first pass metabolism, with bioavailability being only 36%. In the present investigation, an attempt was made to formulate fast dissolving film of fosinopril sodium by Solvent casting method using various film forming polymers such as HPMC 5cps, HPMC E-3, HPMC E-15 each being varied at three different concentration(6%,8%,10%). Drug-excipient compatibility studies were carried out by FTIR spectroscopy and DSC. in order to establish compatibility between drug and excipients The results revealed that the drug and excipients were satisfactorily compatible, without any significant changes in the chemical nature of the drug. Prepared films were subjected to different evaluation parameters such as folding endurance, physical appearance, %moisture absorption,drug content uniformity, in vitro disintegration time, in vitro dissolution studies and stability studies. All the formulations show name accurred compliance with pharmacopoeial standards. The stability study shows that no significant changes in films after one month study. Results revealed that the formulations F1 containing 6% HPMC 5cps showed better release property, low disintegration time, good folding endurance and good physical appearance compared to other formulations, so it was selected as the best formulation.

Author(s):  
Vedanshu Malviya ◽  
Srikant Pande

The intention of the present study was to formulate the oral dispersible film of Fluoxetine hydrochloride using pullulan as a polymer and to evaluate it with the different parameters. The drug-excipients studies were carried out in order to determine any type of incompatibilities by using Fourier transmission infrared spectroscopy (FT-IR). The oral dispersible films were prepared using solvent casting method using pullulan as a polymer. Glycerin was used as a plasticizer. The prepared films were evaluated for the parameters like physical appearance, thickness, folding endurance, In-vitro disintegration, mechanical properties, surface pH, drug content uniformity, taste evaluation, In-vitro dissolution test and stability study. The X5 formulation was found to be stable and appropriate in its evaluation parameters than compared to other formulations. The folding endurance was found to be 259±2.53, disintegration time was found to be 04±0.69, thickness was found to be 0.081±0.003, tensile strength was found to be 5.55, the % elongation was found to be 27.50, the maximum percentage drug release was found to be 95.80% in 30 minutes. The drug content was found to be 99.86 with surface pH of 6.8. In the stability studies of the formulation the product was found to be stable for 90 days. The oral dispersible film is simple to administer and very much effective for the patients and the prepared film of fluoxetine hydrochloride proves to be potential candidate for safe and effective oral dispersible drug delivery.


Author(s):  
R. SANTOSH KUMAR ◽  
ANNU KUMARI ◽  
B. KUSUMA LATHA ◽  
PRUDHVI RAJ

Objective: The aim of the current research is optimization, preparation and evaluation of starch tartrate (novel super disintegrant) and preparation of fast dissolving oral films of cetirizine dihydrochloride by employing starch tartrate. Methods: To check the drug excipient compatibility studies of the selected drug (Cetrizine dihydrochloride) and the prepared excipient i. e starch tartrate, different studies like FTIR (Fourier-transform infrared spectroscopy), DSC (Differential scanning calorimetry) and thin-layer chromatography (TLC) were carried out to find out whether there is any interaction between cetirizine dihydrochloride and starch tartrate. The solvent casting method was used for the preparation of fast dissolving films. The prepared films were then evaluated for thickness, folding endurance, content uniformity, tensile strength, percent elongation, in vitro disintegration time and in-vitro dissolution studies. Response surface plots and contour plots were also plotted to know the individual and combined effect of starch tartrate (A), croscarmellose sodium (B) and crospovidone (C) on disintegration time and drug dissolution efficiency in 10 min (dependent variables). Results: Films of all the formulations are of good quality, smooth and elegant by appearance. Drug content (100±5%), thickness (0.059 mm to 0.061 mm), the weight of films varies from 51.33 to 58.06 mg, folding endurance (52 to 67 times), tensile strength (10.25 to 12.08 N/mm2). Fast dissolving films were found to disintegrate between 34 to 69 sec. Percent dissolved in 5 min were found to be more in F1 formulation which confirms that starch tartrate was effective at 1%. Conclusion: From the research conducted, it was proved that starch tartrate can be used in the formulation of fast dissolving films of cetirizine dihydrochloride. The disintegration time of the films was increased with increase in concentration of super disintegrant.


Author(s):  
S. Jyothi Sri ◽  
D.V. R.N Bhikshapathi

The present investigation was aimed with the objective of developing fast dissolving oral films of Aripiprazole to attain quick onset of action for the better management of Schizophrenia. Fourteen formulations (F1-F14) of Aripiprazole mouth dissolving films by solvent-casting method using HPMC E5, HPMC E15, Maltodextrin, PG and PVA. Formulations were evaluated for their physical characteristics, thickness, folding endurance, tensile strength, disintegration time, drug content uniformity and drug release characteristics and found to be within the limits. Among the prepared formulations F13 showed minimum disintegration time 10 sec, maximum drug was released i.e. 99.49 ± 0.36% of drug within 8 min when compared to the other formulations and finalized as optimized formulation. FTIR data revealed that no interactions take place between the drug and polymers used in the optimized formulation. The in vitro dissolution profiles of marketed product and optimized formulation was compared and found to be the drug released was 20.73 ± 0.25 after 8 min. Therefore, it can be a good alternative to conventional Aripiprazole for immediate action. In vitro evaluation of the Aripiprazole fast dissolving oral films confirmed their potential as an innovative dosage form to improve delivery and quick onset of action of Aripiprazole. The mouth dissolving film is potentially useful for the treatment of Schizophrenia where the quick onset of action is desired.


2021 ◽  
Vol 3 (2) ◽  
Author(s):  
Km. Roshani ◽  
Mangla Nand Singh ◽  
D. Sasmal ◽  
P. D. Panda ◽  
Jai Narayan Mishra ◽  
...  

Etoricoxib belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Etoricoxib acts by reducing the pain and swelling (inflammation) in the joints and muscles of people older than 16 years of age and older patients with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. The present study was aimed to formulate fast dissolving oral films to enhance bioavailability, avoid presystemic metabolism and fast onset of action. The Preformulation studies such as Micromeritics, melting point, partition coefficients, UV spectroscopy, thin layer chromatography, loss on drying were carried out. The fast dissolving oral film was successfully fabricated by solvent casting method. Oral film was fabricated using PVA and PVP polymer. The prepared films were evaluated for Organoleptic evaluations, film weight, thickness, folding endurance, tensile strength, drug content uniformity of films, surface pH, disintegration time and in-vitro dissolution studies and SEM study. The formulation F8 has shown disintegration time of 22±1 seconds and is more promising, showed drug release in phosphate buffer 6.8 pH 86.33% in 10 min. Hence formulation F8 was selected as best formulation. In the stability testing all films stored at elevated temperature showed slight change in pH, other parameters were found to be unchanged.


2019 ◽  
Vol 22 (2) ◽  
pp. 228-234 ◽  
Author(s):  
Sreebash Chandra Bhowmik ◽  
Marzia Alam ◽  
Md Saiful Islam Pathan

The purpose of the current study was to develop a fast dissolving polymeric oral thin film containing palonosetron hydrochloride having good mechanical properties, fast disintegration, dissolution and good drug content uniformity. Solvent casting method was used to prepare the films. Compatibility between drugs and excipients were studied using FTIR and HPLC. Nine different formulations of film from F1 to F9 were prepared using different concentration of polymer A at drug-polymer A ratio (1:26), (1:28), (1:30), (1:32), (1:34), (1:36), (1:38), (1:40), (1:42) and at polymer A-plasticizer B of (65:10), (70:10), (75:10), (40:10), (42.5:10), (45:10), (47.5:10), (50:10), (52.5:10), respectively. The in vitro dissolution study was carried out in phosphate buffer (pH 6.8) at 37±0.5oC and 50 rpm using USP XXIV paddle method. Physicochemical evaluations of all the batches were performed including weight variation, thickness, folding endurance, pH, in vitro disintegration and drug release, FTIR and content uniformity test. Maximum and minimum drug dissolution were found in F6 (108.7%) and in F1 (98.5%), respectively. The maximum and minimum disintegration time were in F9 (43.8 sec) and F1 (25 sec), respectively which demonstrated that disintegration of the film was directly proportional to the polymer A and plasticizer B concentration. It is quite evident from the present research work that the film prepared using polymer A-plasticizer B were smooth, mechanically strong and easy to peel out. Among all the batches, formulation F5 showed best results with respect to disintegration (33 sec), drug dissolution (105%), content uniformity (98.51%) and folding endurance (731). Therefore, it can be said that combination of polymer A and plasticizer B can be prospectively used for the preparation of palonosetron hydrochloride oral thin film. Bangladesh Pharmaceutical Journal 22(2): 228-234, 2019


2019 ◽  
Vol 11 (1) ◽  
pp. 158
Author(s):  
Harikesh Maurya ◽  
Tirath Kumar

Objective: The study was designed as formulation, standardization, and evaluation of polyherbal dispersible tablet prepared for the management of kidney disorders. To overcome the problem of dyspepsia in geriatric patients by the use of polyherbal dispersible tablets.Methods: Dispersible tablets were prepared using aqueous root extract powder of the selected plant viz. A. officinalis, B. diffusa, C. papaya, C. fistula, C. intybus, F. hispida, F. indica, C. nurvala, S. virgaurea, and V. negundo with the help of superdisintegrant addition technique using crospovidone, sodium starch glycolate and croscarmellose sodium in different percentage. Evaluation assessments such as the substantial test, weight variation, hardness, friability, content uniformity, disintegration, in vitro dispersion, stability study and IR compatibility were carried out.Results: Micromeritics of extracts powder were determined for all formulation, which signifying good flow properties. The substantial examination was established, which comply with official requirements for uniformity test, and the drug content was close to 100% in all formulations. Disintegration time was observed for all formulation in which the polyherbal formulation-3 (PHF-3) showing 1.10±0.10 min; during in vitro dispersion time, all formulation showed appropriate dispersion in which the PHF-3 captivating 2.00±0.45 min only. The IR compatibility shows none chemical interaction between the extracts and excipients.Conclusion: The PHF-3 showed satisfactory disintegration and in vitro dispersion time due to crospovidone and reported as the best formulation. The stability study and IR compatibility validate the PHF may represent new easily swallow dispersible tablet that may enhance drug permeability and advance bioavailability for nephrotic patients. 


Author(s):  
SHALLY SHARMA ◽  
NIMRATA SETH ◽  
NARESH SINGH GILL

Objective: The present study aims to formulate and evaluate Fast dissolving tablet of Buspirone, the drug that is used for management of anxiety, by direct compression method using various Super disintegrants. Methods: Ten formulations (F1-F10) of fast dissolving tablets of Buspirone were prepared by using various Superdisintegrants. The prepared tablets were evaluated for hardness, friability, thickness, drug content uniformity, water absorption, wetting time, and disintegration time and in vitro dissolution study. Results: Among all the formulations, F10 (containing 5 mg of Coprocessed (CS: SSG 1:2) Superdisintegrants) was considered to be the best formulation, which released up to 98% drug in 20 min as compared to a marketed conventional dosage form which dissolves in approx 60 min. The results of stability study of formulation F10 after a period of two months indicated that the formulation was stable. Conclusion: It was concluded that a fast-dissolving tablet of Buspirone containing various Superdisintegrants is better and effective to meet patient compliance.


Author(s):  
Bhikshapathi D. V. R. N. ◽  
Srinivas A

The main objective of this study was to develop fast dissolving oral films of ropinirole HCl to attain quick onset of action for the better management of Parkinson’s disease. Twenty-seven formulations (F1-F27) of ropinirole oral dissolving films by solvent-casting method using 33 response surface method by using HPMC E15, Maltodextrin PEG 4000 by using Design of experiment software. Formulations were evaluated for their physical characteristics, thickness, folding endurance, tensile strength, disintegration time, drug content uniformity and drug release characteristics and found to be within the limits. Among the prepared formulations F4 showed minimum disintegration time 11 sec, maximum drug was released i.e. 99.68 ± 1.52% of drug within 10 min when compared to the other formulations and finalized as optimized formulation. FTIR data revealed that no interactions takes place between the drug and polymers used in the optimized formulation. The in vitro dissolution profiles of marketed product and optimized formulation was compared and found to be the drug released was 92.77 ± 1.52 after 50 min. Therefore, it can be a good alternative to conventional ropinirole for immediate action. In vitro evaluation of the ropinirole fast dissolving films confirmed their potential as an innovative dosage form to improve delivery and quick onset of action of ropinirole. The oral dissolving film is considered to be potentially useful for the treatment of Parkinson’s disease where quick onset of action is desired


Author(s):  
MANIKIRAN S. S. ◽  
NAGAM SANTHI PRIYA ◽  
B. AUBINE MOLLY ◽  
LAKSHMI PRASANTHI NORI

Objective: This research focused on the design of fast dissolving herbal film of Eclipta Prostrate leaves extract for mouth ulcers. Methods: The extract of Eclipta Prostrata leaves was formulated as films by solvent casting method using various polymers viz., HPMC E5, HPMC E15, sodium alginate and PVA. The films were designed by using propylene glycol as a plasticizer, SSG as super disintegrate and honey as a sweetener. Furthermore, the films were evaluated for thickness, folding endurance, weight variation, % elongation, surface pH, % moisture uptake, % moisture loss, disintegration and in vitro drug release study. Results: The revealed that all the films were good in appearance and had a smooth texture. Out of all ten formulations, F3 and F5 disintegrated rapidly with a disintegration time of 27 and 32 seconds. The drug release studies revealed that all the formulations had a good release profile, but the F3 formulation showed rapid release i.e. 83.57% in 4 min. The stability studies revealed that the formulations F3 and F5 were found good with non-tackiness, easily separable and disintegrated at 29 and 33 sec respectively with no appearance and drug release. Conclusion: The research revealed that Eclipta prostrate leaves extract can be formulated into oral films for the treatment of mouth ulcers with improved bioavailability and expected patient compliance.


2017 ◽  
Vol 20 (1) ◽  
pp. 64-70
Author(s):  
Md Masud Morshed ◽  
Jewel Mallick ◽  
Fahamida Islam ◽  
Md Kamrul Islam ◽  
Md Didaruzzaman Sohel ◽  
...  

The present study was concerned with the preparation and evaluation of oral thin films of levosalbutamol sulphate (LS) is to avoid presystemic elimination by gastrointestinal degradation and first pass hepatic metabolism. The films were prepared using four different water soluble polymers in various proportions and combinations using propylene glycol as plasticizers. Total five formulations were developed and evaluated for the various physicochemical characteristics namely mass uniformity, thickness, folding endurance, density, surface pH, swelling index, disintegration time, content uniformity, in vitro release profile, percent moisture absorption and loss and ex vivo mucoadhesion time. Data of every parameter were taken in triplicate. Results of film thickness, mass, density and swelling index of medicated films of LS were found with relatively low standard deviation along with high folding endurance (>300). The surface pH of all films approached to the salivary fluid pH range (6.1~7.0). Disintegration time and content uniformity complied with standard for all formulations. Among the total five formulations, F-2 and F-5 followed first order release and F-1 and F-4 followed Higuchi release and F-5 followed zero order and hixon-crowell release. The residence time for mucoadhesion of the tested films ranged between 1 to 5 minutes. Percent moisture absorption and loss study revealed the excellent stability of the films in dried conditions and relatively low standard deviation indicated the stability also in humid conditions.Bangladesh Pharmaceutical Journal 20(1): 64-70, 2017


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