In vitro dissolution studies on commercial brands containing immediate release pioglitazone and metformin hydrochloride extended release tablets

2017 ◽  
Vol 9 (1) ◽  
pp. 15
Author(s):  
K. Soumya ◽  
S. Susanna ◽  
T.E.G.K. Murthy
Keyword(s):  
Extended Release ◽  
Immediate Release ◽  
In Vitro Dissolution ◽  
Metformin Hydrochloride ◽  
Dissolution Studies

scholarly journals COMPARATIVE IN VITRO DISSOLUTION STUDY ON METFORMIN MARKET PRODUCTS USING DIFFERENT DISSOLUTION APPARATUSES

2019 ◽  
pp. 65-72
Author(s):  
HANAN M. HASHEM ◽  
AYA R. ABDOU ◽  
NADIA M. MURSI ◽  
LAILA H. EMARA
Keyword(s):  
Reference Product ◽  
Immediate Release ◽  
In Vitro Dissolution ◽  
Metformin Hydrochloride ◽  
Innovator Product ◽  
Similarity Factor ◽  
Generic Products ◽  
Dissolution Efficiency ◽  
Usp Apparatus

Objective: This study was proposed to evaluate and compare the in vitro dissolution profiles of six Metformin Hydrochloride (MH) market products. Methods: Different dissolution apparatuses (USP apparatus II, IV and beaker method) were used to evaluate the dissolution profiles (in phosphate buffer, pH 6.8) of two immediate release (IR) generic products of Metformin Hydrochloride (MH): Cidophage® 1000 mg (G1, Egyptian market) and Metformin arrow® 1000 mg (G2, French market) with respect to the reference products named Glucophage® 850 mg (R1, Egyptian market and R2, French market). In addition to a generic controlled-release (CR) product; Cidophage Retard® 850 mg (G3) versus the reference product; Glucophage XR® 1000 mg (R3) (both from Egyptian market). Dissolution efficiency (D. E.) and the similarity factor (f2) were calculated. Weight uniformity, hardness, tablet dimensions and MH content were measured. Results: Results of the three apparatuses showed that MH IR products studied (reference and generics) did not meet the 75% USP 30 specifications for MH dissolved at 30 min. For MH CR products, Glucophage XR® did not fulfill the USP release criteria, while Cidophage Retard® did. USP apparatus IV revealed the highest sensitivity and discriminative capability. Conclusion: Generally, MH IR generics (G1 and G2) might be interchangeable with the innovator product (Glucophage®). However, Cidophage Retard® might not be interchangeable with Glucophage XR®.

scholarly journals Extended release promethazine HCl using acrylic polymers by freeze-drying and spray-drying techniques: formulation considerations

2009 ◽  
Vol 45 (4) ◽  
pp. 829-840 ◽  
Author(s):  
Ruchi Tiwari ◽  
Birendra Srivastava ◽  
Gaurav Tiwari ◽  
Awanik Rai
Keyword(s):  
Spray Drying ◽  
Freeze Drying ◽  
Extended Release ◽  
In Vitro Dissolution ◽  
Adsorptive Capacity ◽  
Acrylic Polymers ◽  
Dissolution Studies ◽  
Eudragit S100 ◽  
Drying Techniques

The present study investigated a novel extended release system of promethazine hydrochloride (PHC) with acrylic polymers Eudragit RL100 and Eudragit S100 in different weight ratios (1:1 and 1: 5), and in combination (0.5+1.5), using freeze-drying and spray-drying techniques. Solid dispersions were characterized by Fourier-transformed infrared spectroscopy (FT-IR), differential scanning calorimetry (DSC), Powder X-ray diffractometry (PXRD), Nuclear magnetic resonance (NMR), Scanning electron microscopy (SEM), as well as solubility and in vitro dissolution studies in 0.1 N HCl (pH 1.2), double-distilled water and phosphate buffer (pH 7.4). Adsorption tests from drug solution to solid polymers were also performed. A selected solid dispersion system was developed into capsule dosage form and evaluated for in vitro dissolution studies. The progressive disappearance of drug peaks in thermotropic profiles of spray-dried dispersions were related to increasing amount of polymers, while SEM studies suggested homogenous dispersion of drug in polymer. Eudragit RL100 had a greater adsorptive capacity than Eudragit S100, and thus its combination in (0.5+1.5) for S100 and RL 100 exhibited a higher dissolution rate with 97.14% drug release for twelve hours. Among different formulations, capsules prepared by combination of acrylic polymers using spray-drying (1:0.5 + 1.5) displayed extended release of drug for twelve hours with 96.87% release followed by zero order kinetics (r²= 0.9986).

scholarly journals Formulation and Dissolution Study of Valsartan Immediate Release Tablets

2013 ◽  
Vol 1 (02) ◽  
pp. 01-08
Author(s):  
B. Brahmaiah ◽  
K. Sasikanth ◽  
Sreekanth Nama ◽  
P. Suresh ◽  
Patan Adam Khan
Keyword(s):  
Potato Starch ◽  
Immediate Release ◽  
Magnesium Stearate ◽  
In Vitro Dissolution ◽  
Direct Compression ◽  
Dissolution Profile ◽  
Compression Technique ◽  
Dissolution Studies ◽  
Main Motive

In the present study, design of oral immediate release tablets of Valsartan by direct compression technique was carried out. The main aim and objective of the work is to formulate immediate release tablets using different direct compression vehicles (DCV’S) in different ratios. The main motive is to compare the dissolution profile of these formulations and conclude the best formulation which release drug at a faster rate. To determine the best fit dissolution profile for the dosage forms. Valsartan tablets were formulated by using microcrystalline cellulose (diluents), potato starch, acacia (binder) and magnesium stearate (lubricant). The granules were compressed into tablets and were subjected to dissolution studies. The dissolution profile of the formulation F2 was found to have better dissolution rate compared to others. The In-vitro dissolution studies of all the formulations were conducted and the results were obtained, it was concluded that formulation F2 was the best with fast release of drug compared to others.

scholarly journals Analysis on the evaluation of aceclofenac bilayer tablets and its formulation using FT-IT method

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 323-328
Author(s):  
Umamaheswara Rao T ◽  
Smitha M ◽  
Maghiben M ◽  
Damodara Velayudham A
Keyword(s):  
Immediate Release ◽  
Research Progress ◽  
In Vitro Dissolution ◽  
Burst Release ◽  
Dissolution Studies ◽  
Bilayer Tablets ◽  
Ir Studies ◽  
Bilayer Tablet ◽  
Ft Ir

The detached of the current research progress a bilayer tablet of aceclofenac utilizing sodium starch glycolate (SSG) and croscarmellose sodium (CCS) as super disintegrants for the formulation of immediate-release layer whereas polymers such as methocel K15M, Lubrizol 971P were utilized by the formulation of sustaining layer. The tablets were equipped by straight density technique. The organized tablets were estimated for pre-compressed parameters like micromeritic properties and post compressed parameters like bulk variation, aceclofenac satisfied and in-vitro dissolution studies. The in-vitro dissolution studies showed about 86.78 % of aceclofenac release from the bilayer tablet, indicating that a preliminary burst release of aceclofenac followed by sustaining action up to 12 h by the sustained layer of the tablets. In-Vitro kinetic data revealed that all the formulations surveyed the Higuchi prototype via fickian dispersal as announcement device subsequently the preliminary rupture announcement. FT-IR studies exposed here is no communication among the drug and polymers utilized in the study. The errand of medication is to safeguard and reestablish wellbeing and to soothe languishing. In this context, the most commonly used pain-relieving agent is aceclofenac an NSAID. In the present investigation, aceclofenac bilayer tablets were prepared to provide sustain effect for better therapeutic effect. These points of interest, clarify the requirement for the planning of changed medication conveyance framework.

scholarly journals DEVELOPMENT AND IN VITRO–IN VIVO EVALUATION OF GASTRORETENTIVE FLOATING TABLETS OF AN ANTIRETROVIRAL AGENT RITONAVIR

2019 ◽  
pp. 436-443
Author(s):  
SHIREESH KIRAN R ◽  
CHANDRA SHEKAR B ◽  
NAGENDRA BABU B
Keyword(s):  
Drug Release ◽  
Residence Time ◽  
Extended Release ◽  
In Vitro Dissolution ◽  
Floating Tablets ◽  
Gastric Residence Time ◽  
Dissolution Studies ◽  
Evaluation Parameters

Objective: The present research work concerns the development of the extended release of Ritonavir floating matrix tablets, designed to prolong the gastric residence time, increase the drug bioavailability, and diminish the side effects of irritating drugs. Methods: The floating tablets of Ritonavir were prepared by direct compression method using different grades of hydroxypropyl methylcellulose (HPMC), crospovidone, Polyox WSR 303, and sodium bicarbonate, as gas generating agent. Evaluation parameters and in vivo radiographic studies were conducted in suitable model. Results: Among all formulations, F21 was chosen as optimized formulation based on evaluation parameters such as floating lag time (33 s), total floating time (>24 h), and in vitro dissolution studies. From in vitro dissolution studies, the optimized formulation F21 and marketed product were shown 98.67% and 91.46±5.02% of drug release, respectively. The main appliance of medication discharge follows zero-order kinetics and non- Fickian transport by coupled diffusion and erosion. In vivo experiments maintained the potentials in extending the gastric residence time in the fasted state in beagle dogs. The mean gastric residence time of the optimized formulation found to be 330 min±40 in the stomach, where longer gastric residence time is an important condition for prolonged or controlled drug release and also for enhanced bioavailability. Conclusion: From in vitro and in vivo radiographic studies, Ritonavir floating tablets estimated to provide novel choice for harmless, inexpensive, and extended release for the effective management of AIDS.

scholarly journals Evaluation of a Modified Flow-Through Method for Predictive Dissolution and In Vitro/In Vivo Correlations of Immediate Release and Extended Release Formulations

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hanxi Yi ◽  
Fan Liu ◽  
Guoqing Zhang ◽  
Zeneng Cheng
Keyword(s):  
Extended Release ◽  
Immediate Release ◽  
In Vitro Dissolution ◽  
In Vivo Absorption ◽  
Flow Through ◽  
Felodipine Er ◽  
Extended Release Formulations ◽  
Potential Tool

The present study evaluated the ability of a modified flow-through method for predicting in vivo performance of immediate release (IR) and extended release (ER) formulations. In vitro dissolution of two model drugs, paracetamol IR tablets and felodipine ER tablets, was investigated under tuned conditions using the modified flow-through method and compared with the compendial quality control (QC) basket method. The in vivo absorption properties of paracetamol IR tablets and felodipine ER tablets were investigated in healthy volunteers. In vitro-in vivo correlation (IVIVC) analysis was performed based on the obtained in vitro and in vivo data. Our results demonstrated that the compendial QC method was not able to reflect in vivo actual absorption, while satisfactory discriminatory power and comparable in vitro dissolution/in vivo absorption were achieved for both paracetamol IR tablets and felodipine ER tablets by the modified flow-through method. This study indicated that the modified flow-through method is a potential tool to reflect in vivo performance of the IR and ER formulations.

Formulation and Evaluation of Bilayer Sustained Release Tablets of Salbutamol and Theophylline

2009 ◽  
Vol 2 (3) ◽  
pp. 638-646
Author(s):  
R. Nagaraju ◽  
Rajesh Kaza
Keyword(s):  
Ethyl Cellulose ◽  
Xanthan Gum ◽  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Dissolution Studies ◽  
Sustained Release Tablets ◽  
Dissolution Apparatus ◽  
Single Dosage

Salbutamol and theophylline are available in conventional dosage forms, administered four times a day, leading to saw tooth kinetics and resulting in ineffective therapy. The combination of these two drugs in a single dosage form will enhance the patient compliance and prolong bronchodilation. Various polymers, such as hydroxy propyl methylcellulose K4M (HPMC- K4M), hydroxy propyl methylcellulose K100M (HPMC- K100M), xanthan gum, ethyl cellulose and hydroxy propyl methylcellulose phthalate (HPMC-P) were studied. HPMC-P and HPMC- K4M were found to be best in controlling the release. In-vitro dissolution studies were carried out for all the bi-layered tablets developed using USP dissolution apparatus type 2 (paddle). It was found that the tablet FB15-FW3 showed 50% release of salbutamol in first hour and the remaining was released for eight hours. However, theophylline was found to be released as per the USP specifications. The IR spectrum was taken for FB15-FW3 formulation and it revealed that there is no disturbance in the principal peaks of pure drugs salbutamol and theophylline. This further confirms the integrity of pure drugs and no incompatibility of them with excipients. Also, formulation of FB15-FW3 has shown required release pattern and complies with all the evaluated parameters and comparable to the marketed formulation.

scholarly journals An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products

Pharmaceutics ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 507
Author(s):  
Isabel Gonzalez-Alvarez ◽  
Marival Bermejo ◽  
Yasuhiro Tsume ◽  
Alejandro Ruiz-Picazo ◽  
Marta Gonzalez-Alvarez ◽  
...  
Keyword(s):  
Plasma Concentrations ◽  
In Vitro Dissolution ◽  
Case Examples ◽  
Dissolution Studies ◽  
Weak Bases ◽  
Transit Times ◽  
Class Iib ◽  
The Impact

The purpose of this study was to predict in vivo performance of three oral products of Etoricoxib (Arcoxia® as reference and two generic formulations in development) by conducting in vivo predictive dissolution with GIS (Gastro Intestinal Simulator) and computational analysis. Those predictions were compared with the results from previous bioequivalence (BE) human studies. Product dissolution studies were performed using a computer-controlled multicompartmental dissolution device (GIS) equipped with three dissolution chambers, representing stomach, duodenum, and jejunum, with integrated transit times and secretion rates. The measured dissolved amounts were modelled in each compartment with a set of differential equations representing transit, dissolution, and precipitation processes. The observed drug concentration by in vitro dissolution studies were directly convoluted with permeability and disposition parameters from literature to generate the predicted plasma concentrations. The GIS was able to detect the dissolution differences among reference and generic formulations in the gastric chamber where the drug solubility is high (pH 2) while the USP 2 standard dissolution test at pH 2 did not show any difference. Therefore, the current study confirms the importance of multicompartmental dissolution testing for weak bases as observed for other case examples but also the impact of excipients on duodenal and jejunal in vivo behavior.

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