scholarly journals Stability studies of hydralazine hydrochloride orodispersible formulations

2020 ◽  
Vol 11 (1) ◽  
pp. 75-86
Author(s):  
Muthukumar ◽  
Sundaraganapathy R ◽  
Sankar C ◽  
Sundaramoorthy C ◽  
Yuvaraja K R

Solid dosage forms also have a impervious difficulties in patients especially for geriatric and paediatric patients.Dysphagia is common among all age groups. Orodispersible formulations (Fast  dissolving tablets & Fast dissolving oral thin films) constitute an inventive dosage form that overcome the problems swallowing and provides speedy onset of action. The objective of present study was to formulate orodispersible formulations of Hydralazine HCL by different methods (Direct compression method, Sublimation method and solvent casting method). Based on physiochemical evaluations F9 (Direct compression method),SF9 (Sublimation method) for Fast dissolving tablets and H2 formulations (Solvent casting method) for Fast dissolving oral thin films were found optimized formula.The optimized formula were kept for stability under long term, accelerated and intermediate conditions for the study period of six months as per ICH guidelines.Based on stability reports the H2 formulations (Fast dissolving oral thin films) got a better drug release than Fast dissolving tablets.

2019 ◽  
Vol 9 (6) ◽  
pp. 206-210
Author(s):  
Rajat Pawar ◽  
Ravi Sharma ◽  
Pravin Sharma ◽  
G.N. Darwhekar

Mouth dissolving film is the most advanced oral solid dosage form due to its flexibility and comfort in use. Mouth dissolving films are oral solid dosage form that disintegrate and dissolve within a minute when placed in mouth without taking water or chewing. This dosage form allows the medication to bypass the first pass metabolism so bioavailability of medication may be improved .Mouth dissolving film has potential to improve onset of action lower the dosing and eliminate the fear of chocking. Formulation of mouth dissolving films involves both the visual and performance characteristics as plasticized hydrocolloids, API taste masking agents are being laminated by solvent casting and semisolid casting method. Solvent casting method being the most preferred method over other methods because it offers great uniformity of thickness and films prepared having fine glossy look and better physical properties. Mouth dissolving films are evaluated for its various parameters like thickness, physical property like folding endurance, disintegration and dissolution time. This review gives an idea about formulation techniques, evaluation parameters, overview on packaging and some available marketed products of mouth dissolving films. Keywords: Mouth dissolving film, solvent casting, fast disintegration


Author(s):  
Sudhakar Kancharla ◽  
Prachetha Kolli ◽  
Dr.K.Venkata Gopaiah

Oral Disintegrating Tablets of Triazolam were formulated with an aim to improve the versatility, patient compliance, and accurate dosing. The formulations ere developed with an objective to use by the pediatric and geriatric patients. Triazolam Oral Disintegrating Tablets were prepared by direct compression method using cross povidone, croscarmellose sodium, sodium starch  glycolate and combinations of CP+CCS, and CP + SSG as super disintegrates exhibited good pre-formulation and tableting properties of three super disintegrates, the formulation contained combination of CP + CCS showed better performance in terms of disintegration time when compared to other formulations. Order of the super disintegrates activity is as follows. (CP + CCS) > (CP + SSG) > CP > CCS >SSG The formulation F15 was found to be the best among all twenty Triazolam ODT formulations because it has exhibited faster disintegration time (17.66 sec) when compared to the other formulations and it showed 99.87±0.18% drug release at the end of 25 min. Triazolam Oral Disintegrating Films were prepared by solvent casting method using different grades of Hydroxypropyl Methyl Cellulose like HPMC – E15, HPMC – 5cps, HPMC – 50cps. Based on disintegration and dissolution results it was concluded that the formulation F15 contained CP 5% + CCS 5% was the best formulation among all otherformulations.


Author(s):  
Y. Shravan Kumar ◽  
R Gowthami ◽  
Sujitha H ◽  
Nagaraju T ◽  
Rajashekar M ◽  
...  

Sumatriptan succinate is a 5-HT1B/1D receptor agonist which has well established efficacy in treating migraine. The main objective of the study was to formulate Oral Fast Disintegrating Films (ODF) and Oral Fast Disintegrating Tablets (ODT) to achieve a better dissolution rate and further improving the bioavailability of the drug.  ODFs were prepared by solvent casting method using film forming polymers like HPMC – E15,5cps,50cps in different ratios & prepared batches of films were evaluated for the drug content, film thickness, disintegration time  and in vitro dissolution studies. Among the prepared formulation F7 containing HPMC – 50cps (drug: polymer ratios = 1:1) was found to be best formulations which releases 98.2±1.1of the drug within 17±0.02 sec. ODTs prepared by direct compression method using in different concentrations of super-disintegrants. The prepared formulation T12 (combination of disintegrants) containing CP + CCS (6%) was considered to be the best formulation, which releases up to 100±0.38% of the drug in 23±0.75 sec, respectively. Based on these results, it is suggested that ODFs have faster disintegration time and drug release than ODTs.  


Author(s):  
Pratiksha S. Deore ◽  
Yashpal M. More ◽  
Avish D. Maru

The aim of present work is to formulate and develop tablets of promethazine HCL.by using various superdisintegrating agent by direct compression method. The main objective of the study is to increase rapid onset of action of promethazine HCL in the treatment of nausea and vomiting. The orodispersible tablet of promethazine hcl is were prepared by direct compression method. Using different concentration of Crospovidone, croscarmellose sodium Mannitol, lactose, maltose, mg. stearate. The tablet was evaluated by various parameters and result are found to be satisfactory.


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.


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.


2020 ◽  
Vol 10 (1) ◽  
pp. 182-188
Author(s):  
Rozhan A. Muhammed ◽  
Huner K. Omer

Fast dissolving oral film is a new emerging solid dosage form in which it consists of thin strips administered orally and dissolved in mouth within the seconds. The study is purposed to use water soluble polymers to provide rapid film disintegration as the films are hydrated in mouth and to find the best polymer type and its concentration to formulate the drug. Initially, placebo films were prepared using solvent casting method then two formulations from the prepared placebo films were selected to formulate imipramine. The excipients were dissolved in water then the drug solution was prepared by dissolving 150 mg of drug in 5 ml of water then mixed with the excipients and they were mixed gently and casted in disposable Petri dishes and left for 24 h in oven to provide film dryness. Then, the films removed from Petri dish and cut to 2 cm × 2 cm small strips. Then, the tests were performed. Successful films were prepared by 45% hydroxypropyl methyl cellulose (HPMC) and 50% sodium carboxymethyl cellulose (NaCMC). The films were smooth, easily removed from Petri dish without tearing and homogenous. The thin films were mechanically stable that they could be handled without breaking due to their good folding endurance which was more than 400. The pH of the films was accepted since they were around saliva pH (5.3–6.9). The films disintegration time was <60 min since water-soluble polymers were used and this property provided rapid drug release from the formulation in which it was 15–20 min for both of the drug-containing films, while dissolution time for the imipramine conventional tablet was about 60 min. Imipramine can be formulated as a new dosage form (fast dissolving film) using 45% HPMC and 50% NaCMC as polymer using solvent casting method to ease the drug administration for psychotic and pediatric patients since no water is required for this solid dosage for administration.


2014 ◽  
Vol 695 ◽  
pp. 187-190
Author(s):  
Nima Moazeni ◽  
Zurina Mohamad ◽  
Nazila Dehbari

A biodegradable poly-lactic acid (PLA)/Sepiolite nanocomposite films were prepared by the thermo-compression and solvent-casting methods, and barrier properties (water-vapor and gas barrier) were evaluated. By introducing sepiolite into PLA, the properties of nanocomposite films improved until a certain amount (1.5% wt). By increasing sepiolite loading, nanoparticles tented to agglomerate and gas permeability (GP) decreased. According to the results, the nanocomposite films prepared by the thermo-compression method were more brittle but strong due to the formation of more crystals; while solvent-casted films were more ductile due to the presence of solvent, which may act as a plasticizer, as evidenced by the results of the GP.


Author(s):  
Fariba Safaei ◽  
Shahla Khalili ◽  
Saied Nouri Khorasani ◽  
Laleh Ghasemi-Mobarakeh ◽  
Rasoul Esmaeely Neisiany

In this study, the effect of porogenic solvents on pore size distribution of the polycaprolactone (PCL) thin films was investigated. Five thin PCL films were prepared using the solvent-casting method. Chloroform, Methylene Chloride (MC) and three different compositions of MC/ Dimethylformamide (DMF) (80/20, 50/50 and 20/80) were used as solvents. Scanning Electron Microscopy (SEM) investigations were employed to study morphology and consequently the pore size distribution of the prepared films. The PCL films made by chloroform and MC as a solvent were completely non-porous. Whereas the other films (made by a combination of MC and DMF) showed both uni-modal and bi-modal pore size distributions.


2020 ◽  
Vol 13 (4) ◽  
pp. 341-349
Author(s):  
B. M. Kadu ◽  
S. Bhasme ◽  
R. D. Bawankar ◽  
D. R. Mundhada

A. Rapimelt tablet of Lorazepam was prepared by direct compression method using Indion 414, Cross Carmellose Sodium and sodium starch glycolate as superdisintegrants with aim to get rapid onset of action, improve bioavailability and to give pleasant taste and better mouth feel. The tablets prepared were evaluated for various parameters like various density parameters, thickness, hardness, friability, disintegration time, wetting time and invitro dissolution time and were found to be within limits as per Indian Pharmacopoeia. FT-IR spectra of physical mixture of Lorazepam with Indion 414showedretention of basic peaks of Lorazepam. The developed formulation of Lorazepam batch F5 (10% Indion 414) showed good palatability and dispersed within 30 seconds as compared to Crosscarmellose Sodium batches F1-F3 and Sodium starch glycolate batches F6-F9.


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