CEFPODOXIME PROXETIL FAST DISSOLVING TABLETS: COMPARATIVE STUDY

2020 ◽  
pp. 35-41
Author(s):  
INDER KUMAR ◽  
VINAY PANDIT
Keyword(s):  
In Vitro Study ◽  
In Vitro Dissolution ◽  
Direct Compression ◽  
Onset Of Action ◽  
Cefpodoxime Proxetil ◽  
Ich Guidelines ◽  
Croscarmellose Sodium ◽  
Percentage Release ◽  
One Way Anova

Objective: In the present investigation, fast dissolving tablets of cefpodoxime proxetil were formulated using superdisintegrants to impart fast disintegration. Methods: In the current study, 12 formulations of fast dissolving tablets of cefpodoxime proxetil were formulated using two different approaches viz., direct compression and sublimation. Three different superdisintegrants viz., croscarmellose sodium, sodium starch glycolate, and crospovidone were used in a different concentration in all the respective formulations. The final powder blend was subjected for the pre-compression evaluation and all the formulations were evaluated for post-compression parameters. Stability studies were also evaluated for the best formulations as per ICH guidelines. Finally, results were statistically analyzed by the application of one way ANOVA test and t-test. Results: Among all the formulations of different approaches, formulation cefpodoxime proxetil 4 (CP4) containing 6% crospovidone as a super disintegrant was showed the best results. In vitro dissolution data revealed that formulation CP4 prepared by direct compression method showed 99.387±0.270% drug release within 15 min whereas the percentage release by formulation prepared by using sublimation showed 83.927±0.735% release. The optimized formulation was further subjected to comparative in vitro study with two marketed formulation of different brands. Conclusion: All the data of all formulations is shows that direct compression approach is the best approach for developing the fast dissolving tablets to enhance the onset of action and bioavailability.

scholarly journals EFFECT OF EFFERVESCENCE IN COMBINATION WITH SUPERDISINTEGRANTS IN THE FORMULATION OF PROPRANOLOL HCL ORAL DISINTEGRATING TABLETS

2017 ◽  
Vol 10 (3) ◽  
pp. 227
Author(s):  
Ashok Thulluru ◽  
Veeravalli Kumar Sai ◽  
Pavan Kumar M ◽  
Roshitha B
Keyword(s):  
Citric Acid ◽  
Dissolution Rate ◽  
Research Work ◽  
In Vitro Dissolution ◽  
Direct Compression ◽  
Onset Of Action ◽  
Orally Disintegrating Tablet ◽  
Sodium Starch Glycolate ◽  
Propranolol Hcl ◽  
Croscarmellose Sodium

ABSTRACTObjective: The current research work is intended to formulate propranolol HCl (PLH) as orally disintegrating tablet (ODT). It is also intending to checkthe superiority in a combination of superdisintegrants and effervescent mixture than the use of superdisintegrants alone by a direct compressiontechnique. To fasten the onset of action and thereby enhancing the bioavailability of PLH in comparison to its conventional tablets.Methods: Standard calibration curve of PLH was obtained in pH 6.8 phosphate buffer by spectrophotometric method, drug-excipient compatibilitystudies were carried by Fourier transform infrared (FT-IR) studies. All the formulations were evaluated for pre and postcompression studies.Accelerated stability studies were carried out up to 6 months for the optimized formulation, EF3.Results and Discussion: Superdisintegrants used in the study are compatible with PLH. Pre- and post-compression parameters were within theacceptable limits for all formulations. In vitro dissolution kinetic studies indicate the release of PLH from ODT increases as the concentration ofsuperdisintegrants as well as the ratio of citric acid: NaHCO3 of effervescent mixture increases. Formulations with an effervescent mixture are havingrapid disintegration and dissolution rate when compared to the formulations with superdisintegrants alone. The order of superdisintegrants inenhancing the dissolution rate of PLH is crospovidone (CPV) > croscarmellose sodium (CCS) > sodium starch glycolate (SSG). Formulation, EF3 (10%CPV and 1:3, citric acid: NaHCO3 ratio, respectively) had the highest dissolution efficiency at 10 minutes (DE10=82.74%); the first order dissolutionrate constant (K1=0.141/minutes) with a regression coefficient (r2=0.974) and lesser time for 90% of drug release (t90=4 minutes), was considered asthe optimal ODT in this study. Formulation EF3, passed the test for stability.Conclusion: Hence, an effective PLH ODT was formulated by the direct compression technique with disintegration by combination of superdisintegrantsand effervescent mixture, will fasten the onset of action and enhances the bioavailability of PLH in comparison to its conventional tablets.Keywords: Propranolol HCl, Orally disintegrating tablet, Sodium starch glycolate, Croscarmellose sodium, Crospovidone, Direct compression, In vitrodissolution studies.

scholarly journals Formulation and evaluation of taste masked oral disintegrating tablets of lornoxicam

2021 ◽  
Vol 11 (5) ◽  
pp. 115-120
Author(s):  
Kritika Rai ◽  
Vivek Jain ◽  
Sunil Kumar Jain ◽  
Pushpendra Kumar Khangar
Keyword(s):  
Cation Exchange Resin ◽  
The Elderly ◽  
In Vitro Dissolution ◽  
Taste Masking ◽  
Direct Compression ◽  
Compression Technique ◽  
Disintegration Time ◽  
Weight Variation ◽  
Croscarmellose Sodium

Orally disintegrating tablets (ODT) disintegrate quickly with saliva when administered into the oral cavity and taken without water or chewed. ODT are easy to take for children and the elderly, who may experience difficultly in taking ordinary oral preparations such as tablets, capsules, and powders.  The ODT threes substantial benefits for the patient (or elder) who cannot swallow (Dysphagia), or who is not permitted water intake due to disease. The reason of the current research was to prepare taste masking oral disintegrating tablets of poorly soluble lornoxicam (LXM) by direct compression technique using Kyron T-114 (cation exchange resin) as a taste masking agent. With in various ratios the Drug-resin of 1:4 was established to present best taste masking. The superdisintegrants used in formulation are croscarmellose sodium and cross povidone. Among these croscarmellose sodium demonstrated superior drug release. The tablets were evaluated for friability, weight variation, wetting time, hardness, disintegration time and uniformity of content. Optimized formulations were evaluated for in vitro dissolution test. Amongst all the formulations F-6 was found to be most successful tablets prepared by this technique had disintegration time of 30sec and % CDR 94.78 within 30min. Hence, this advance can be utilized for taste masking of bitter pharmaceutical ingredients leading to superior patient compliance. Keywords: Oral disintegration tablets, Lornoxicam, Kyron T-114, Superdisintegrants, Direct Compression.

FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF LORATADINE SOLID DISPERSION USING SUPER DISINTEGRANTS

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (08) ◽  
pp. 84-87
Author(s):  
S Kumar ◽  
J. V. Kumar ◽  
P Singhal ◽  
Keyword(s):  
Solid Dispersion ◽  
In Vitro Dissolution ◽  
Dissolution Behavior ◽  
Direct Compression ◽  
Compression Method ◽  
Equilibrium Solubility ◽  
Sodium Starch Glycolate ◽  
Croscarmellose Sodium ◽  
Dispersion Technique

The aim of the present investigation was to prepare solid dispersion (SD) of the water insoluble drug. Loratadine using super disintegrants as carrier and formulate it as fast dissolving tablets (FDTs) with an objective to improve solubility and enhance dissolution of drug. The SD’s of the drug were prepared by melt dispersion technique using polyethylene glycol (PEG) 6000 in diferent ratios 1 : 2.5, 1 : 5 and 1 : 7.5. The prepared SD formulations were characterized for equilibrium solubility, Fourier Transform Infrared spectroscopy (FTIR) and in vitro dissolution study. The batch containing SD formulation of loratadine showed fastest dissolution (99.87% drug release in 60 min). In this study, fast dissolving tablets were prepared by direct compression method using Croscarmellose sodium, sodium starch glycolate and polyplasdone XL as the super disintegrants. Effect of various super disintegrants on dissolution behavior of tablets was evaluated in phosphate buffer pH 6.8.

Gastroretentive System of Fluvastatin Sodium by Using Natural Mucilage and Synthetic Polymer

2014 ◽  
Vol 4 (2) ◽  
Author(s):  
Umamaheswara G. ◽  
Anudeep D.
Keyword(s):  
Half Life ◽  
Release Kinetics ◽  
Kinetic Studies ◽  
Diffusion Path ◽  
Synthetic Polymer ◽  
In Vitro Dissolution ◽  
Direct Compression ◽  
Drug Content ◽  
Biological Half Life

Fluvastatin sodium is a novel compound used as cholesterol lowering agent which acts through the inhibition of 3- hydroxyl-3- methyl glutaryl- coenzyme A (HMG-Co A) reductase. It has short biological half life (1-3h) in humans required a dosing frequency of 20 to 40mg twice a day. Due to its short variable biological half life it has been developed to a sustained gastroretentive system with a natural and synthetic polymer and to study how far the natural mucilage improves the sustained activity. Floating tablets were prepared by direct compression method using in combination of natural mucilage and synthetic polymer. Prior to the preparation of tablets the physical mixtures were subjected to FT IR studies and pre compression parameters. After preparation of tablets they were subjected to various tests like swollen index, drug content, In vitro dissolution and release kinetics with pcp disso software etc. The tablets prepared by direct compression shown good in thickness, hardness and uniformity in drug content, the prepared tablets floated more than 12h except FS1 and FS2 shows 9 and 11h. Swollen index studies shows with increase in concentration of polymer the swelling increases the diffusion path length by which the drug molecule may have to travel and cause lag time. In vitro results shows that on increasing the amount of hibiscus polymer the sustain activity is increased because of its integrity and forms a thick swollen mass and reduces the erosion property of the HypromelloseK100M, kinetic studies shows that FS 1, FS2, FS3 followed the Korsmeyer peppas model and the rest FS 4, FS 5, FS6 follows the zero order respectively. Based on n value indicating that the drug release followed super case II transport mechanism due to the erosion of the polymer.

Design, Optimization and Evaluation of Fast-Dissolving Oral Films of Ropinirole

2018 ◽  
Vol 11 (1) ◽  
pp. 3958-3967
Author(s):  
Bhikshapathi D. V. R. N. ◽  
Srinivas A
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Good Alternative ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Onset Of Action ◽  
Disintegration Time ◽  
Peg 4000 ◽  
Oral Films

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

Formulation and Evaluation of Orally Disintegrating Tablets of Lamotrigine

2015 ◽  
Vol 8 (2) ◽  
pp. 2881-2888
Author(s):  
Sudarshan Singh ◽  
S S Shyale ◽  
P Karade
Keyword(s):  
Drug Release ◽  
Water Soluble ◽  
In Vitro Dissolution ◽  
Disintegration Time ◽  
Orally Disintegrating Tablet ◽  
Drug Content ◽  
Weight Variation ◽  
Wetting Time ◽  
Croscarmellose Sodium

The aim of this study was to design orally disintegrating tablet (ODT) of Lamotrigine. It is an Antiepileptic drug which is widely used in epilepsy. It is also used in simple and complex partial seizures and secondary generalized tonic-clonic seizures. It is poorly water soluble drug (0.46 mg/ml). Thus, an attempt was made to enhance the water solubility by complexation with β-cyclodextrin (1:1 molar ratios). The orally disintegrating tablet of lamotrigine was prepared by direct compression method using different concentration of superdisintegrants such as Sodium starch glycollate, croscarmellose sodium by sublimating agent such as camphor. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies. The prepared tablets were characterized by Fourier transform infrared spectroscopy and differential scanning calorimetry. The disintegration time for the complexed tablets prepared by different concentration of superdisintegrants was found to be in range of 32.54 ± 0.50 to 55.12 ± 0.57 sec and wetting time of the formulations was found to be in range of 28.47 ± 0.67 to 52.19 ± 0.72 sec. All the formulation showed almost 100 percent of drug release within 15 min. Among all the formulation F6 and F7 prepared with 18% croscarmellose sodium and camphor shows faster drug release, respectively 10 min, F6 gives good result for disintegration time, drug release, wetting time and friability. Further formulations were subjected to stability testing for 30 days at temperature of 40 ± 5 ºC/75 ± 5 %RH. Tablets showed no appreciable changes with respect to physical appearance, drug content, disintegration time and dissolution profiles. Results were statistically analyzed by one-way ANOVA at a p < 0.05. It was found that, the data at any point of time are significant at p < 0.05.

scholarly journals Onset of acid-neutralizing action of a calcium/magnesium carbonate-based antacid using an artificial stomach model: an in vitro evaluation

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maxim Voropaiev ◽  
Deborah Nock
Keyword(s):  
In Vitro Study ◽  
Magnesium Carbonate ◽  
Human Gastrointestinal Tract ◽  
Pepsin Activity ◽  
Onset Of Action ◽  
Over The Counter ◽  
Calcium Magnesium ◽  
Secondary Objective ◽  
Time Required

Abstract Background Calcium carbonate antacids are potent over-the-counter antacids, made more effective by adding magnesium carbonate (as in Rennie, Bayer). However, published studies on their onset of action are scarce. Therefore, we carried out an in vitro study comparing Rennie and placebo under simulated conditions of the human stomach (artificial stomach model) to reconfirm the onset of action of Rennie. Methods The validated Simulator of the Human Intestinal Microbial Ecosystem apparatus (SHIME, ProDigest, Belgium) was used, comprising five reactors simulating different parts of the human gastrointestinal tract. Both Rennie and placebo were dosed at two tablets per incubation over six independent, 2-h stomach incubations each. Primary objectives: to evaluate the time required to achieve pH 3.0, 3.5, 4.0 and 4.5, as well as the maximum pH reached. Secondary objective: to evaluate pepsin activity over the entire 2-h gastric incubation. Results After addition of Rennie, the gastric medium reached a pH of 3.0 within 40 s. The maximum pH of 5.24 was maintained for almost 10 min. In contrast, the maximum pH with placebo was 1.28 during the entire gastric simulation. Furthermore, Rennie strongly reduced the activity of mucosa-damaging pepsin during the period of increased pH. With placebo, the lower pH resulted in consistently high loads of digested peptides, reflecting the high cumulative and instantaneous pepsin activity. Conclusions New data is a critical component in informed decision making. Our data confirm the high efficacy and fast onset of acid-neutralizing action of Rennie, which begins to work within seconds.

Assessment of 2D ultrasound fluid volume estimation accuracy in different shaped objects: an in vitro study

2019 ◽  
Vol 61 (2) ◽  
pp. 253-259
Author(s):  
Iroshani Kodikara ◽  
Iroshini Abeysekara ◽  
Dhanusha Gamage ◽  
Isurani Ilayperuma
Keyword(s):  
Estimation Error ◽  
In Vitro Study ◽  
High Accuracy ◽  
Volume Estimation ◽  
Estimation Accuracy ◽  
Rater Agreement ◽  
Actual Volume ◽  
2D Ultrasound ◽  
One Way Anova

Background Volume estimation of organs using two-dimensional (2D) ultrasonography is frequently warranted. Considering the influence of estimated volume on patient management, maintenance of its high accuracy is empirical. However, data are scarce regarding the accuracy of estimated volume of non-globular shaped objects of different volumes. Purpose To evaluate the volume estimation accuracy of different shaped and sized objects using high-end 2D ultrasound scanners. Material and Methods Globular (n=5); non-globular elongated (n=5), and non-globular near-spherical shaped (n=4) hollow plastic objects were scanned to estimate the volumes; actual volumes were compared with estimated volumes. T-test and one-way ANOVA were used to compare means; P<0.05 was considered significant. Results The actual volumes of the objects were in the range of 10–445 mL; estimated volumes ranged from 6.4–425 mL ( P=0.067). The estimated volume was lower than the actual volume; such volume underestimation was marked for non-globular elongated objects. Regardless of the scanner, the highest volume estimation error was for non-globular elongated objects (<40%) followed by non-globular near-spherical shaped objects (<23.88%); the lowest was for globular objects (<3.6%). Irrespective of the shape or the volume of the object, volume estimation difference among the scanners was not significant: globular (F=0.430, P=0.66); non-globular elongated (F=3.69, P=0.064); and non-globular near-spherical (F=4.00, P=0.06). A good inter-rater agreement (R=0.99, P<0.001) and a good correlation between actual versus estimated volumes (R=0.98, P<0.001) were noted. Conclusion The 2D ultrasonography can be recommended for volume estimation purposes of different shaped and different sized objects, regardless the type of the high-end scanner used.

scholarly journals ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 363
Author(s):  
Claudia Miranda ◽  
Alexis Aceituno ◽  
Mirna Fernández ◽  
Gustavo Mendes ◽  
Yanina Rodríguez ◽  
...  
Keyword(s):  
Latin American ◽  
Classification System ◽  
Biopharmaceutics Classification System ◽  
In Vitro Dissolution ◽  
Ich Guidelines ◽  
Latin American Region ◽  
Regulatory Guidelines ◽  
Biopharmaceutics Classification

The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.

Formulation and Evaluation of Orodispersble Tablet

2021 ◽  
pp. 267-272
Author(s):  
Pratiksha S. Deore ◽  
Yashpal M. More ◽  
Avish D. Maru
Keyword(s):  
Rapid Onset ◽  
Nausea And Vomiting ◽  
Direct Compression ◽  
Compression Method ◽  
Onset Of Action ◽  
Orodispersible Tablet ◽  
Croscarmellose Sodium

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.

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