scholarly journals Development and Evaluation of Fluoxetine Fast Dissolving Films: An Alternative for Noncompliance in Pediatric Patients

Processes ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 778
Author(s):  
Emőke-Margit Rédai ◽  
Paula Antonoaea ◽  
Nicoleta Todoran ◽  
Robert Alexandru Vlad ◽  
Magdalena Bîrsan ◽  
...  

The most used pharmaceutical formulations for children are syrups, suppositories, soft chewable capsules, and mini-tablets. Administrating them might create an administration discomfort. This study aimed to develop and evaluate orodispersible films (ODFs) for pediatric patients in which the fluoxetine (FX) is formulated in the polymeric matrix. Six FX fast dissolving films (10 mg FX/ODF), FX1, FX2, FX3, FX4, FX5, and FX6, were prepared by solvent casting technique. In the composition of the ODFs, the concentration of the hydroxypropyl methylcellulose and the concentration of the propylene glycol were varied. Each formulation of fluoxetine ODF was evaluated by determining the tensile strength, folding endurance, disintegration, behavior in the controlled humidity and temperature conditions, and adhesiveness. All the obtained results were compared with the results obtained for six ODFs prepared without FX. The disintegration time of the FX ODFs was of maximum 88 s for FX2. Via the in vitro releasing study of the FX from the ODFs it was noticed that FX1 and FX2 allow a better release of the drug 99.98 ± 3.81% and 97.67 ± 3.85% being released within 15 min. From the obtained results it was also confirmed that FX ODFs were found to follow first-order release kinetic.

2019 ◽  
Vol 41 (3) ◽  
pp. 469-469
Author(s):  
Muhammad Naeem Aamir Muhammad Naeem Aamir ◽  
Aneela Manzoor Aneela Manzoor ◽  
Hina Hussain Hina Hussain ◽  
Zeeshan Javaid Zeeshan Javaid ◽  
Tariq Mahmood Tariq Mahmood ◽  
...  

To deliver maximum amount of paroxetine in shortest duration of time, the orodispersible films (ODF) were formulated and tested for their suitability as a carrier system. ODF were prepared by using hydroxypropyl methylcellulose and polyvinyl alcohol and different superdisintegrants at a specific proportion. The newly developed ODF were subjected to characterization for folding endurance, weight variations, thickness, disintegration time, drug release pattern and drug content. The surface morphology of orodispersible film was examined by means of scanning electron microscope. Moreover physical compatibility between the drug and excipients was guaranteed in the orodispersible film by Fourier transform infrared spectroscopy. It was found that all films prepared were transparent, smooth and elegant in appearance. ODF showed good folding endurance, uniform thickness, weight and drug content. The surface pH of all orodispersible film was found to be neutral and they disintegrate within few seconds. FTIR spectroscopy supported compatible among all excipients and they can be used together in formulation. It was concluded that stable paroxetine orodispersible films can be made by solvent casting technique with ultrafast dissolution rate.


Author(s):  
SHUBHAM BIYANI ◽  
SARANG MALGIRWAR ◽  
RAJESHWAR KSHIRSAGAR ◽  
SAGAR KOTHAWADE

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.


Author(s):  
Bikash Pandey ◽  
Arshad Bashir Khan

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.


Author(s):  
ANAGHA PRABHU ◽  
ASMITA ARONDEKAR Arondeka ◽  
PRASHANT BHIDE ◽  
SHWETA BORKAR

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.


Author(s):  
Sura Zuhair Mahmood ◽  
Hiba Sabah Sabry ◽  
Nora Zawar Yousif ◽  
Zeina D Salman

Objective: The goal of performing this study is to prepare an oral strip, especially designed for pediatric use that provides fast onset of action with ease of swallowing particularly for young individuals who suffer from difficulty of swallowing, in addition provides maximum therapeutic effectiveness by reducing the first pass effect.Materials and Methods: The oral strip was prepared by solvent casting technique through using different sole polymers (hydroxypropyl methylcellulose [HPMC] 15cp, HPMC 50cp, polyvinyl alcohol, and sodium carboxymethyl cellulose). Maltodextrin (MD) was added as the secondary polymer in different ratios to optimize the release parameters, and disintegration time (DT), three different plasticizers were employed (propylene glycol, dibutyl phthalate, and glycerin) to boost the film forming polymer characteristics.Results: From this study, it is obvious that F10 which composed of HPMC as a main polymer and MD as a secondary polymer in ratio 2:1, respectively, provides adequate physicochemical characteristics, in vivo/in vitro DT (40/36 s), respectively, nevertheless a satisfactory release parameters as (59.9%) released at 2 min and 80% of drug released at 14.8 min.Conclusion: The optimized formula is pretty encouraging to originate an oral strip that provides ease of administration, fast onset of action with wide acceptance for the pediatric population.


Author(s):  
Zainab E Jassim ◽  
Mais F Mohammed ◽  
Zainab Ahmed Sadeq

Objective: The aim of the present work was to formulate and evaluate fast dissolving film containing lornoxicam.Materials and Methods: To prepare the film, hydroxypropyl methylcellulose E5 and polyvinyl alcohol (PVA) were used as film-forming polymers by solvent casting method. Glycerine was used as plasticizer, aspartame, and mannitol as sweetener. All prepared films were evaluated for its weight variation, disintegration time, thickness, drug content, pH, dissolution study, and folding endurance. The drug-excipients compatibility study was done using differential scanning calorimetry (DSC) and Fourier transform infrared (FTIR).Results: Satisfactory results obtained when PVA was used as film-forming polymer, and the drug was dispersed in the polymer solution using poloxamer 407 as a solubilizing agent. Formulation F2 is considered as the optimized formulation as it showed good folding endurance (>300), faster disintegration rate (30 s), and maximum in vitro drug release (87%) within 5 min. DSC and FTIR studies showed no interaction between drug and the polymers.Conclusion: It can be concluded from the study that the fast dissolving film can be prepared for poorly water-soluble drug lornoxicam using PVA as a suitable film-forming polymer.


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.


2021 ◽  
Vol 30 (Sup9a) ◽  
pp. IVi-IVx
Author(s):  
Chukwuma O Agubata ◽  
Mary A Mbah ◽  
Paul A Akpa ◽  
Godwin Ugwu

Aim: Self-healing, swellable and biodegradable polymers are vital materials that may facilitate the different stages of wound healing. The aim of this research was to prepare wound healing films using self-healing polyvinyl alcohol (PVA), swellable hydroxypropyl methylcellulose (HPMC), biodegradable polyglycolic acid (PGA) sutures and ciprofloxacin antibiotic for improved treatment outcome. Methods: Films were formulated through aqueous-based mixing of varying amounts of polyvinyl alcohol (10–20% weight/weight (w/w)) and hydroxypropyl methylcellulose (0.5, 1% w/w) with fixed quantities of ciprofloxacin. PGA sutures were placed as grids within the wet mixtures of the polymers and ciprofloxacin, and thereafter products were air dried. The formulated films were evaluated for swelling ratio, breaking elongation, folding endurance, moisture uptake and loss, compatibility and in vitro antibiotic release. Furthermore, in vivo wound healing was studied using excision model and histopathological examinations. Results: Swelling ratios were above 1.0 and the films were minimally stretchable, with folding endurance greater than 500. Films were stable while moisture uptake and loss were observed to be less than 30%. Among the optimised hydrogel batches, those containing 10% w/w PVA and 1% w/w HPMC with no PGA showed the highest drug release of 73%, whereas the batches with higher PGA content showed higher percentage wound size reduction with minimal scar. The completeness of wound healing with batches containing PVA, HPMC, ciprofloxacin and PGA, along with the standard, is evident considering the massive cornification, regeneration of the epithelial front and stratum spinosum. Conclusion: The findings show that polymer-based multifunctional composite films are suitable for use as dressings for improved wound healing.


Pharmaceutics ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 470 ◽  
Author(s):  
Konstantina Chachlioutaki ◽  
Emmanouil K. Tzimtzimis ◽  
Dimitrios Tzetzis ◽  
Ming-Wei Chang ◽  
Zeeshan Ahmad ◽  
...  

Child-appropriate dosage forms are critical in promoting adherence and effective pharmacotherapy in pediatric patients, especially those undergoing long-term treatment in low-resource settings. The present study aimed to develop orodispersible films (ODFs) for isoniazid administration to children exposed to tuberculosis. The ODFs were produced from the aqueous solutions of natural and semi-synthetic polymer blends using electrospinning. The spinning solutions and the resulting fibers were physicochemically characterized, and the disintegration time and isoniazid release from the ODFs were assessed in simulated salivary fluid. The ODFs comprised of nanofibers with adequate thermal stability and possible drug amorphization. Film disintegration occurred instantly upon contact with simulated salivary fluid within less than 15 s, and isoniazid release from the ODFs in the same medium followed after the disintegration profiles, achieving rapid and total drug release within less than 60 s. The ease of administration and favorable drug loading and release properties of the ODFs may provide a dosage form able to facilitate proper adherence to treatment within the pediatric patient population.


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