scholarly journals Development and Optimization of Fast Dissolving Oral Film Containing Aripiprazole

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.

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


2020 ◽  
Vol 10 (3-s) ◽  
pp. 107-110
Author(s):  
Aashish Marskole ◽  
Sailesh Kumar Ghatuary ◽  
Abhishek Parwari ◽  
Geeta Parkhe

Oral fast dissolving midodrine hydrochloride films prepared by solvent casting method, PEG 400 was the selected plasticizers, incorporating superdisintegrants such as croscarmellose sodium (CCS) and sodium starch glycolate (SSG) to achieve the goal. Drug content, weight variability, film thickness, disintegration time, endurance, percentage of moisture content, and in vitro dissolution tests were analyzed for the prepared films. In all formulations, the tensile strength value was found from 0.965±0.045 and 1.256±0.032 and the folding capacity was over 100. The assay values ranged from 97.98±0.25 to 99.89±0.36 percent for all formulations. The disintegration time was ranging between 55±9 to 120±6 sec, the minimum time for disintegration was found in formulation F5 (55±9). The prepared F5 formulation shows greater release of the drug (99.25±0.41 percent) within 15 min relative to other formulations. As the drug having low solubility, fast disintegration may leads to more drug availability for dissolution, resulting in faster absorption in systemic circulation increased systemic availability of drug leads to quick onset of action which is prerequisite for hypertension. Keywords: Midodrine hydrochloride, Fast dissolving films, Solvent casting method, Superdisintegrants.


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 9 (4-A) ◽  
pp. 122-125
Author(s):  
Yadagiri Phalguna ◽  
Haritha Pasupulati ◽  
Sandhya Rudra

The predominant goal of this work is to formulate and evaluate Cetirizine HCl ODF’s the usage of Sodium starch glycolate (SSG) as superdisintegrant, Sodium alginate as polymer and Glycerol as plasticizer. Films were prepared by way of Solvent casting method and evaluated for thickness, folding endurance, percentage elongation, floor pH and disintegration time. The consequences indicate that method prepared with 17.5% combo of polymer and plasticizer was determined to be optimized. The three special formulations F1, F2 and F3 of CTZ motion pictures were organized via solvent casting technique the usage of sodium alginate as polymer, SSG as disintegrant and glycerol as plasticizer. Menthol was once used as cooling agent along with aspartame as sweetener and citric acid as a style overlaying agent. The formulation (F3) with presence of superdisintegrant and combo of polymer, plasticizer confirmed first-rate results. Keywords: Cetirizine HCl, Oral thin film, superdisintegrant, polymer, plasticizer


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.


2018 ◽  
Vol 6 (3) ◽  
pp. 5-16 ◽  
Author(s):  
ABRAHAM LINKU ◽  
JOSEPH SIJIMOL

The aim of present work was the development of fast dissolving oral film of Loratadine to overcome the limitations of current routes of administration, to provide immediate action and increase the patient compliance. To improve the bioavailability of the drug, fast dissolving oral film were formulated using different grades of Hydroxy Propyl Methyl Cellulose(HPMC) and various plasticizers like Polyethylene Glycol(PEG) 400, glycerol, Propylene glycol(PG) by solvent casting method. The formulated films were evaluated for film thickness, surface pH, folding endurance, weight variation, % moisture loss, exvivo permeation study, tensile strength, % elongation, drug content uniformity, in vitro dissolution studies,in vitro disintegration test and in vivo study. The optimized formulation (F9) containing HPMC E5 and glycerol showed minimum disintegration time (10.5 s), highest in vitrodissolution (92.5%) and satisfactory stability. Ex vivo permeation study of optimized formulation showed a drug release of 80.6% within 10 min. The milk induced leucocytosis inrat proved that fast dissolving oral films of Loratadine produced a faster onset of action compared to the conventional tablets. These findings suggest that fast dissolving oral film of Loratadine could be potentially useful for treatment of allergy where quick onset of action is required.


Author(s):  
P. Vamsee Kumar ◽  
Y. Shravan Kumar

In current investigation an attempt has been made to formulate and evaluate Quinapril mouth dissolving films using HPMC 50cps, E5, E15 and in combination of Pullulan by Solvent evaporation method. Sodium starch glycolate acts as a super disintegrating agent and it is shown that as the concentration of the super disintegrates increases the disintegration time decreases. The films were evaluated for weight variation, surface pH, folding endurance, drug content, dissolving time, disintegration time, and in-vitro dissolution studies. Based on the evaluation parameters F17 was to be optimized formulation. The optimized film (F17) showed the more drug release i.e 99.40 ± 5.30% within 7 min, lowest in vitro disintegration time 10 sec. FTIR studies proved no drug polymer interaction takes place. These results revealed that fast dissolving films of Quinapril could be formulated for quick onset of action which is required in the efficient management of hypertension.


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):  
Y Shravan Kumar ◽  
Deepthi B ◽  
Mounika M

Salbutamol is a short-acting, selective beta-2-adrenergic receptor agonist used in treatment of asthma and COPD. In the present work, sublingual films of Salbutamol sulphate were developed with a view to enhance the patient compliance and provide quick onset of action. Salbutamol has a bioavailability of 53 - 60%. The goal of the study was to formulate sublingual films of Salbutamol sulphate to achieve a better dissolution rate and further improving the bioavailability of the drug. Sublingual films prepared by solvent casting method using film forming polymers HPMC-E5, HPMC-E15 and Maltodextrin in different ratios. The prepared batches of films were evaluated for the drug content, weight variation, film thickness, disintegration time and in vitro dissolution studies. Among all, the formulation B1 containing HPMC-E15 with a drug: polymer ratio (1:6) was found to be the best formulation which showed 98.36% of the drug release within 15 minutes and disintegration time 18 sec. This study shows the viability of developing sublingual films of salbutamol.    


Author(s):  
Shrushti V. Somwanshi ◽  
Sanjay S. Thonte

The present study aimed at preparing fast dissolving oral films of Eletriptan as a model drug which is used for the migraine treatment. Fast dissolving dosage forms have acquired great importance in pharmaceutical industry because of their unique properties. In the present research work various trials were carried out using different grades of HPMC E3, E6, and E15, maltodextrin DE6 and other polymers by solvent casting method. The prepared films were evaluated for film thickness, folding endurance, surface pH, morphological properties, % drug content and content uniformity, tensile strength, percent elongation, in vitro disintegration time and in vitro dissolution studies. The optimized formulation F24 prepared using HPMC E15 showed minimum disintegration time (10 sec), highest dissolution rate i.e. 99% of drug within 8 min and satisfactory physicochemical properties. The optimized film was evaluated for its bioavailability compared with pure drug as reference standard. Statistical analysis revealed that no significant difference between the bioavailability parameters of the film and the reference standard indicated that they exhibited comparable plasma level-time profiles. These findings suggest that the fast dissolving film containing Eletriptan is considered to be potentially useful for the treatment of migraine where quick onset of action is desirable.


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