Invitro dissolution studies of lansoprazole EC pellets 12% w/w – A comparative dissolution profile with reference sample

2018 ◽  
Vol 9 (4) ◽  
Author(s):  
VENKATESWARA REDDY BOYA ◽  
DR. K. S. SEKHARA RAO
Keyword(s):  
Reference Sample ◽  
Dissolution Profile ◽  
Dissolution Studies ◽  
Comparative Dissolution

scholarly journals COMPARATIVE DISSOLUTION STUDIES OF WARFARIN SODIUM TABLETS: INFLUENCE OF AGITATION RATE, DISSOLUTION MEDIUM, AND USP APPARATUS

2021 ◽  
pp. 117-123
Author(s):  
JOSE RAUL MEDINA LOPEZ ◽  
LUIS DANIEL MAZON ROMAN ◽  
JUAN MANUEL CONTRERAS JIMENEZ ◽  
JUAN CARLOS RUIZ-SEGURA
Keyword(s):  
In Vitro Release ◽  
Agitation Rate ◽  
Dissolution Medium ◽  
Dissolution Studies ◽  
Warfarin Sodium ◽  
Flow Through ◽  
Vitro Release ◽  
Comparative Dissolution ◽  
Paddle Apparatus

Objective: The aim of this study was to carry out comparative dissolution studies with warfarin sodium reference tablets under the hydrodynamic environments generated by the USP basket and paddle apparatus and flow-through cell using different agitation rates and dissolution media. Methods: Dissolution profiles were obtained with the USP basket and paddle apparatus at 50, 75, and 100 rpm and 900 ml of water as dissolution medium. After this, dissolution profiles of warfarin sodium were obtained with the USP paddle apparatus and flow-through cell method using 0.1 N hydrochloric acid, acetate buffer pH 4.5, phosphate buffer pH 6.8, and water. Spectrophotometric determination at 308 nm was carried out during 30 min. Dissolution profiles were compared with model-independent and model-dependent approaches. Results: Significant differences were found with mean dissolution time and dissolution efficiency at 50 and 75 rpm (*P<0.05). Makoid-Banakar was the best-fit model used to describe the in vitro release performance of warfarin sodium with 50-100 rpm and the USP basket and paddle apparatuses. Significant differences in all calculated parameters were found (*P<0.05) excepting percent dissolved at 30 min with 0.1 N hydrochloric acid and phosphate buffer pH 6.8. Conclusion: More research is necessary to identify the in vitro release performance of poorly soluble drugs under available USP apparatuses considering factors as agitation rate and kind of dissolution media. The knowledge of the in vitro release performance of reference drug products is important for the design of better generic formulations

scholarly journals Dissolution Advantage of Nitazoxanide Cocrystals in the Presence of Cellulosic Polymers

Pharmaceutics ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 23 ◽  
Author(s):  
Reynaldo Salas-Zúñiga ◽  
Christian Rodríguez-Ruiz ◽  
Herbert Höpfl ◽  
Hugo Morales-Rojas ◽  
Obdulia Sánchez-Guadarrama ◽  
...  
Keyword(s):  
Hydroxypropyl Methylcellulose ◽  
Dissolution Behavior ◽  
Dissolution Profile ◽  
Solid Dosage ◽  
Dissolution Studies ◽  
Key Factor ◽  
Pharmaceutical Powder ◽  
Poorly Soluble ◽  
Fast Dissolution ◽  
Cellulosic Polymer

The effect of hydroxypropyl methylcellulose (HPMC) and methylcellulose (Methocel® 60 HG) on the dissolution behavior of two cocrystals derived from nitazoxanide (NTZ), viz., nitazoxanide-glutaric acid (NTZ-GLU, 1:1) and nitazoxanide-succinic acid (NTZ-SUC, 2:1), was explored. Powder dissolution experiments under non-sink conditions showed similar dissolution profiles for the cocrystals and pure NTZ. However, pre-dissolved cellulosic polymer in the phosphate dissolution medium (pH 7.5) modified the dissolution profile of NTZ when starting from the cocrystals, achieving transient drug supersaturation. Subsequent dissolution studies under sink conditions of polymer-based pharmaceutical powder formulations with NTZ-SUC cocrystals gave a significant improvement of the apparent solubility of NTZ when compared with analogous formulations of pure NTZ and the physical mixture of NTZ and SUC. Scanning electron microscopy and powder X-ray diffraction analysis of samples recovered after the powder dissolution studies showed that the cocrystals undergo fast dissolution, drug supersaturation and precipitation both in the absence and presence of polymer, suggesting that the solubilization enhancement is due to polymer-induced delay of nucleation and crystal growth of the less soluble NTZ form. The study demonstrates that the incorporation of an appropriate excipient in adequate concentration can be a key factor for inducing and maintaining the solubilization of poorly soluble drugs starting from co-crystallized solid forms. In such a way, cocrystals can be suitable for the development of solid dosage forms with improved bioavailability and efficacy in the treatment of important parasitic and viral diseases, among others.

scholarly journals Uji Disolusi Terbanding Tablet Ofloxacin Berlogo dan Generik Bermerek Terhadap Inovator Dalam Media Dapar HCl pH 4,5

2017 ◽  
Vol 4 (1) ◽  
Author(s):  
Winsa Wira Wijaya ◽  
Prima Happy Ratnapuri ◽  
Mia Fitriana
Keyword(s):  
Acetate Buffer ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Branded Drug ◽  
Similarity Factor ◽  
Difference Factor ◽  
Zwitter Ion ◽  
Dissolution Efficiency ◽  
Comparative Dissolution

ABSTRAK Uji disolusi terbanding merupakan pengujian yang dapat digunakan untuk memastikan ekivalensi dan sifat-sifat produk obat. Uji disolusi terbanding dilakukan dalam media disolusi dengan pH yang disesuaikan dengan kondisi in vivo yaitu pada pH 1,2; 4,5; dan 6,8. Obat generik dan generik bermerek yang wajib uji ekivalensi salah satunya yaitu ofloxacin. Ofloxacin merupakan suatu obat yang memiliki sifat kationik, anionik, dan zwitter ion. Penelitian ini bertujuan untuk menentukan ekivalensi profil disolusi terbanding yang dianalisis dengan parameter f1, f2, dan DE70 antara ofloxacin generik berlogo dan generik bermerek terhadap inovator dalam media dapar asetat pH 4,5. Uji disolusi dilakukan sesuai USP 32-NF 27 yaitu menggunakan alat uji tipe 2 pada suhu 37 ± 0,50C dengan kecepatan putar 50 rpm. Analisis hasil yang digunakan untuk menentukan ekivalensi profil disolusi yaitu difference factor (f1), similarity factor (f2), dan dissolution efficiency (DE70). Hasil penelitian ini memberikan kesimpulan bahwa sampel yang memiliki ekivalensi profil disolusi terbanding yang dianalisis dengan parameter f1, f2, dan DE70 terhadap produk inovator dalam media dapar asetat pH 4,5 yaitu sampel A (generik bermerek) dan sampel B (generik berlogo). Kata kunci : ofloxacin, disolusi terbanding, difference factor (f1), similarity factor (f2), dan dissolution efficiency (DE70). ABSTRACT Comparative dissolution is a test that can be used to ensure equivalence and properties of medicinal products. Comparative dissolution test has done in a dissolution medium with pH adjusted to in vivo conditions at pH 1,2; 4,5; and 6,8. One of generic and generic branded drug that need equivalence test is ofloxacin. Ofloxacin is a drug which are cationic, anionic, and zwitter ion. The aim of this study was to determine equivalence comporative of dissolution profiles, then analyzed with f1, f2, and DE70 parameters between generic and generic branded to innovators ofloxacin in media acetate buffer pH 4,5. Dissolution test was accordance to USP 32-NF 27 that used equipment test type 2 at temperature 37 ± 0,50 C with rotary speed 50 rpm. The analysis results were used to determine equivalence dissolution profile e.g. difference factor (f1), similarity factor (f2), and dissolution efficiency (DE70). The results this study showed that samples had equivalence comporative of dissolution profiles which were analyzed with f1, f2, and DE70 parameters to innovator product in media acetate buffer pH 4,5 was sample code A (generic branded) and sample code B (generic). Keywords: ofloxacin, comparative dissolution, difference factor (f1), similarity factor (f2), and dissolution efficiency (DE70).

scholarly journals Formulation of Once a Day Controlled Release Tablet of Indomethacin Based on HPMC-Mannitol

1970 ◽  
Vol 4 (1) ◽  
pp. 55-67 ◽  
Author(s):  
Roshan Pradhan ◽  
Uttam Budhathoki ◽  
Panna Thapa
Keyword(s):  
Controlled Release ◽  
Hydroxypropyl Methylcellulose ◽  
Reference Sample ◽  
Methyl Cellulose ◽  
Matrix Tablets ◽  
In Vitro Dissolution ◽  
Matrix Tablet ◽  
Dissolution Profile ◽  
Key Words Indomethacin ◽  
Viscosity Grade

p>A hydroxypropyl methylcellulose (HPMC K4M, HPMC K15M, and HPMC K100M) matrix tablet containing Indomethacin along with mannitol was formulated as a function of HPMC viscosity, and was compared with the commercial products. The release characteristics of the matrix tablet were investigated in the intestinal fluid, 6.8 pH phosphate buffer for 12 hours. The formulated products and two marketed products as reference sample were studied for its different physicochemical parameters and in vitro dissolution studies. It was found that the drug release profile decreases with increase in viscosity of polymer and, with increase polymer level in the formulations. Matrix tablets formulated employing Drug:HPMC K15M:mannitol::1:0.25:1 and Drug:HPMC K15M:mannitol::1:0.25:2 gave slow release of indomethacin spread over 12 hours and their dissolution profiles were compared with the Indian marketed product. The dissolution profiles of both the formulations were similar to the dissolution profile of the marketed product, the similarity factor being 74.59 and 68.04 respectively. The dissolution profiles of formulations containing same viscosity grade of HPMC in remarkably different concentrations and different viscosity grade of HPMC in same concentrations were different. Key words: Indomethacin; Controlled release; Hydroxypropyl methyl cellulose; Mannitol; Dissolution. DOI: 10.3126/kuset.v4i1.2884 Kathmandu University Journal of Science, Engineering and Technology Vol.4, No.1, September 2008, pp 55-67

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 Enhancement of Solubility And Dissolution Profile of Clopidogrel By Various Solid Dispersion Formulations

2020 ◽  
pp. 377-383
Author(s):  
Mohammed Abdul Khader ◽  
Roshan Salfi
Keyword(s):  
Solid Dispersion ◽  
Antiplatelet Agent ◽  
Pluronic F127 ◽  
Poloxamer 407 ◽  
Drug Dissolution ◽  
Dissolution Profile ◽  
Solvent Evaporation Method ◽  
Dissolution Studies ◽  
Ftir Studies ◽  
Pure Drug

The present research is aimed at enhancing solubility and drug dissolution of clopidogrel (CPG) used as oral antiplatelet agent by employing solid dispersion (SD) technique. Total 40 SDs formulated with  drug: polymers (pluronic F127, poloxamer 407, labrafil PG, PEG 6000, gelucire 50/13), in varying ratios (1:0.5, 1:1, 1:2, 1:3, 1:4) of which CPG1 to CPG20 and CPG21 to CPG40 prepared by adopting solvent evaporation  method fusion (melt) method respectively. The formulation CPG40 containing pluronic F127 as polymer showed highest solubility of 6.57±0.04 mg/ml) that is 45 folds than pure drug. Similar results  reflected in the dissolution studies where CPG40 containing CPG: pluronic F127 in 1:4 ratio showed maximum % drug content, % practical yield and drug dissolution of 99.14% in 60 minutes when compared with other formulations and pure drug (32.76%) obtained  by fusion melt method. From FTIR studies the optimized formulation CPG40 showed the compatibility between drug and polymers. XRD and SEM studies showed CPG40 exists in amorphous form that fetched in better drug release from the SD formulation in comparison to pure drug.

scholarly journals Dissolution Profile of Ibuprofen Solid Dispersion Prepared with Cellulosic Polymers and Sugar by Fusion Method

1970 ◽  
Vol 4 (1) ◽  
pp. 31-37 ◽  
Author(s):  
Nadia Saffoon ◽  
Yeakuty Marzan Jhanker ◽  
Naz Hasan Huda
Keyword(s):  
Solid Dispersion ◽  
Dosage Form ◽  
Solid Dispersions ◽  
Dissolution Profile ◽  
Fusion Method ◽  
Method Evaluation ◽  
Dissolution Studies ◽  
Dissolution Properties ◽  
Rate Of Dissolution ◽  
Cellulosic Polymers

The purpose of this study was to prepare and characterize solid dispersions of the NSAID Ibuprofen with HPMC, HPC, icing sugar, dextrose, mannitol and lactose with the intention of improving its dissolution properties. The solid dispersions were prepared by the fusion method. Evaluation of the properties of the dispersions was performed using dissolution studies. The results obtained showed that the rate of dissolution of Ibuprofen was considerably improved when formulated in solid dispersions with HPMC and HPC. Solid dispersions with icing sugar, dextrose, mannitol and lactose showed drug retarding capability which may trigger more research in the intension of exploiting this feature to prepare sustained release dosage form.   Key words: Ibuprofen; Solid dispersion; Fusion method; Dissolution rate. DOI: http://dx.doi.org/10.3329/sjps.v4i1.8864 SJPS 2011; 4(1): 31-37

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