scholarly journals Quality Attributes Comparison of Selected Brands of Rosuvastatin Calcium Tablets Marketed in the US and Bangladesh

2021 ◽  
pp. 46-55
Author(s):  
Shahrin Tasnim Monisha ◽  
Kamrun Nahar Ela ◽  
Rabeya Islam ◽  
Sadia Afruz Ether ◽  
Fahad Imtiaz Rahman
Keyword(s):  
United States Pharmacopeia ◽  
Disintegration Time ◽  
Weight Variation ◽  
The Us ◽  
Generic Products ◽  
Chemical Attributes ◽  
Physical And Chemical ◽  
States Pharmacopeia ◽  
Rosuvastatin Calcium

Aims: This study investigated whether locally marketed rosuvastatin calcium tablets in Bangladesh have comparable physical and chemical attributes, including in vitro bioequivalence profiles, to the proprietary brand. Methodology: Nine generic products (G1-G9) containing 10 mg of rosuvastatin calcium were compared to the proprietary brand Crestor® (R1) and an FDA approved generic rosuvastatin calcium tablet (R2). Weight variation, diameter, thickness, friability, drug content, disintegration time and dissolution profiles were tested according to United States Pharmacopeia (USP) guidelines. In vitro bioequivalence requirements were assessed by calculating difference (f1) and similarity (f2) factors. Results: The generic products complied with the pharmacopeial requirements for weight variation, disintegration time and friability. All the tablets had drug ranging between 92%-105% and released more than 80% of rosuvastatin within first 15-30 minutes. However, for brands G5, G7 and G8 the f1 values were 15.7%, 15.82% and 25.21% respectively and their f2 values were 41.8, 41.6 and 32.6 respectively whereas for G9 the f2 value was 43.4. These brands have thus failed to meet in vitro bioequivalence requirements. Conclusion: We conclude that few substandard generics of rosuvastatin calcium has somehow found its way to the market and further studies are required to ascertain their noncompliance.

scholarly journals Comparative In Vitro Evaluation Of Different Brands Of Metformin Hydrochloride Film Coated Tablets Marketed In Addis Ababa, Ethiopia

2020 ◽  
Vol 8 (3) ◽  
pp. 44-50
Author(s):  
Kassa Abatea ◽  
Abrham Temesgen ◽  
Muluken Nigatu
Keyword(s):  
United States ◽  
Addis Ababa ◽  
United States Pharmacopeia ◽  
Metformin Hydrochloride ◽  
Disintegration Time ◽  
Weight Variation ◽  
Generic Products ◽  
Release Study ◽  
States Pharmacopeia

Metformin hydrochloride is a biguanide class of drug widely used to treat Type 2 diabetes mellitus. Its oral bioavailability is about 50 to 60 % with a half-life of about 3 h. This study focused on evaluation and comparison of the physicochemical properties of different brands of metformin hydrochloride (500mg) film coated tablets available in drug retail outlets in Addis Ababa, Ethiopia. Some different in vitro tests including hardness, weight variation, disintegration time, dissolution study, and assay were conducted as per United States Pharmacopeia. To compare dissolution profiles of the generic products against the innovator product (product A), a model independent method, similarity factor (f2), was also used.  Weight variation result showed that all brand fall within the 5% limit from the average which is acceptable. Disintegration time of less than 15 minutes was observed for all brands. The in vitro drug release study results for the products ranged between 82 and 93% release within 30 minutes which is above 80% limit as per the United States Pharmacopeia requirement. The similarity f2 values for generic products ranged from 53 to 75%. Furthermore, assay value of the studied brands varied from 95.60 to 104.37% which was within standard limit (95-105%). It can be concluded that all brands of metformin hydrochloride tablets met pharmacopoeial specification for the tested parameters of physicochemical properties like weight variation, hardness of tablets, disintegration time, drug release study and assay.  

Post–market In vitro Equivalency Evaluation of Paracetamol Tablets in Kedah, Malaysia

2011 ◽  
Vol 4 (2) ◽  
pp. 1403-1407
Author(s):  
Chandrasekaran A R ◽  
Chen Yi Han ◽  
Alex Chin Yang Chung ◽  
Lim Wei Cheang ◽  
Low Sing Ping
Keyword(s):  
United States ◽  
Quality Control ◽  
United States Pharmacopeia ◽  
Disintegration Time ◽  
British Pharmacopoeia ◽  
Time Profiles ◽  
Post Market ◽  
Tablet Hardness ◽  
States Pharmacopeia

 Six brands of paracetamol (acetaminophen) 500 mg tablets have been evaluated using specific quality control tests for uniformity of weight, hardness, friability, content, disintegration and dissolution with the aim to assess its bioequivalence. The results obtained have been discussed in details using monographs in United States Pharmacopeia and British Pharmacopoeia. In conclusion, despite some apparent minor differences in tablet hardness and disintegration time profiles, the dissolution characteristics of various paracetamol tablets appears to be similar and not significantly different from various manufacturers.  

A Comparative Study of Quality on Conventional Paracetamol Tablets Available in Pakistan

2016 ◽  
Vol 2 (3) ◽  
pp. 205-210
Author(s):  
Muhammad Saquib Qureshi ◽  
Gul Rukh ◽  
Pooja Deepak Kirplani ◽  
Asiya Farheen ◽  
Madhia Hamid
Keyword(s):  
United States ◽  
Quality Control ◽  
Physical Characteristics ◽  
United States Pharmacopeia ◽  
Disintegration Time ◽  
Over The Counter ◽  
Quality Control Laboratory ◽  
Weight Variation ◽  
Label Claim ◽  
States Pharmacopeia

Background: Paracetamol (Acetaminophen) is used as over the counter (OTC) medicine for relief of pain and fever. Paracetamol is available in different brands in Pakistani pharmaceutical market. Objective: To assure the quality control parameters of different brands of paracetamol in Pakistan. Methodology: The pharmaceutical and chemical equivalence of five brands of paracetamol were assessed. For ethical concerns, the brands were coded as PRC-1, PRC-2, PRC-3, PRC-4 and PRC-5. Study was conducted in quality control laboratory of Adamjee Pharmaceuticals during December 2015 to February2016. Identification, physical characteristics, thickness, diameter, weight variation, hardness, disintegration time, percent label claim (Assay) and dissolution rate were calculated for each brand using monographs of British Pharmacopeia and United States Pharmacopeia. Results: Identification, physical characteristics, thickness, diameter, weight variation, hardness, and disintegration time, percent label claim (Assay), and dissolution ratewere calculated for each brand and the results were within the specifications provided by British Pharmacopeia and United States Pharmacopeia. Conclusion: All the brands selected in the study showed results within the limits assuring quality standards of manufacturing.

Formulation and Evaluation of Atenolol and Indapamide SR Matrix Tablets for Treatment of Hypertension

2014 ◽  
Vol 7 (2) ◽  
pp. 2450-2458
Author(s):  
Sarika Pundir ◽  
Ashutosh Badola
Keyword(s):  
Kinetic Studies ◽  
Film Coating ◽  
Matrix Tablets ◽  
Wet Granulation ◽  
Simultaneous Estimation ◽  
Matrix Tablet ◽  
Release Agent ◽  
Disintegration Time ◽  
Weight Variation

In the present study we have formulated (F1 to F6) matrix tablets of atenolol and indapamide for the management of hypertension. As in simultaneous estimation of these drugs it was found that a confined release can be formulated. In the formulation of SR matrix tablet by using different concentration of delayed release agent DCP and pregelatinized starch as disintegrant we prepared tablets by wet granulation method. For sustained release action HPMC polymers were used for film coating. Preformulation studies were performed prior to compression. The compressed SR matrix tablets were evaluated for weight variation, hardness, friability, drug content, disintegration time and in vitro drug release using USP dissolution apparatus type 2 (paddle). It was found that the optimized formulation showed 49.33%, 48.90%, 48.52%, 47.65%, 46.84% and 46.51% release for atenolol in 12 hours respectively. However, indapamide released 49.62%, 49.39%, 48.72%, 48.27%, 47.59% and 47.36% at the end of 12 hr. The IR spectrum study revealed that there is no disturbance in the principal peaks of pure drugs atenolol and indapamide. This confirms the integrity of pure drugs and no incompatibility of them with excipients. The stability studies were carried out for the optimized batch for one months and it showed satisfactory results. The kinetic studies of the formulations revealed that diffusion is the predominant mechanism of drug and release follows Zero-order, Super case II transport.

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.

Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets

2021 ◽  
pp. 255-258
Author(s):  
Bhavana Habib ◽  
Jyoti Mittha
Keyword(s):  
Quality Control ◽  
Quality Evaluation ◽  
Indian Market ◽  
Disintegration Time ◽  
Innovator Product ◽  
Drug Content ◽  
Weight Variation ◽  
Generic Products

The aim of the present study was the evaluation and comparison between four different Metformin and Vildagliptin tablets which are commercially available in Indian market. These tablets were assessed for various pharmacopoeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (three generic and an innovator). These results show that the tested generic products were biopharmaceutically similar to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.

SYNTHESIS AND CHARACTERIZATION OF THIOLATED GUM KONDAGOGU AND EVALUATION AS MUCOADHESIVE POLYMER

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (01) ◽  
pp. 37-43
Author(s):  
Ashwin A. Patil ◽  
Ketan B. Patil ◽  
Laxmikant R. Zawar
Keyword(s):  
Drug Release ◽  
Release Kinetics ◽  
Matrix Tablet ◽  
Disintegration Time ◽  
Weight Variation ◽  
Zero Order Release ◽  
Gum Kondagogu ◽  
Ellman’S Method

Present work focused on thiolation for enhancing the mucoadhesive potential of Gum kondagogu (GK). Thiolation of GK was done by esterification process with 80 % thioglycolic acid in presence of 7N HCl. Thiolated Gum kondagogu (ThioGK) was determined to possess 1.59 ±0.04 mmol of thiol groups/g of the polymer by Ellman’s method. ThioGK was characterized by FTIR, NMR, DSC, XRD, and FE-SEM. The tablets were prepared by direct compression using 75 mg of ThioGK and GK. Tablets containing ThioGK (F1) and GK (F2) were subjected to evaluation of weight variation, hardness and friability and show enhanced disintegration time, swelling behavior, drug release and mucoadhesion. In vitro drug release of batch F1 exhibits complete release of drug in 24 hr with zero order release kinetics. Comparative mucoadhesive strength was studied using chicken ileum by texture analyzer and revealed higher mucoadhesion of tablet containing ThioGK. From the above study, ThioGK was suitability exploited as mucoadhesive sustained release matrix tablet.

Formulation and Evaluation of Orodispersible Tablets Containing Taste Masked Mirabegron Resinate

2021 ◽  
pp. 4736-4742
Author(s):  
Sarika S. Malode ◽  
Milind P. Wagh
Keyword(s):  
Overactive Bladder ◽  
Bitter Taste ◽  
In Vitro Release ◽  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Disintegration Time ◽  
Orodispersible Tablets ◽  
Weight Variation

The objective of present work was to develop taste masked orodispersible tablets of mirabegron. Mirabegron is beta 3 adrenoceptor agonist used to treat overactive bladder. Overactive bladder (OAB) is defined as a symptom syndrome showing feeling of urgency to urinate, typically accompanied by frequent daytime and nocturnal urination, in the absence of proven infection or other obvious pathology. Over active bladders are generally common in geriatrics. Moreover, this drug has a very strong bitter taste. Frequent dosing requires frequent water intake, which further aggregates the condition of over active bladder and bitter taste of drug affects patient compliance. Hence a need arises to mask the bitter taste for development of an ODT which does not require consuming water with every dosage. In this work, the bitter taste of mirabegron was masked by forming a complex with an ion exchange resin tulsion 344. The drug resin complexation process was optimized for resin activation, drug: resin ratio, soaking time and stirring time. In –vitro release studies revealed complete drug elution from the complex within 10 minutes in pH 1.2 buffer. The taste-masked complex was then formulated into palatable orodispersible tablets using a direct compression approach by use of superdisintegrants to achieve a rapid disintegration. The tablets were evaluated for weight variation, hardness, friability, drug content, wetting time, In- vivo disintegration time and in-vitro dissolution time.

scholarly journals FORMULATION AND EVALUATION OF FLURBIPROFEN FAST DISINTEGRATING TABLETS USING NATURAL SUPERDISINTEGRANTS

2016 ◽  
Vol 9 (6) ◽  
pp. 247 ◽  
Author(s):  
Mohammed Sarfaraz ◽  
Surendra Kumar Sharma
Keyword(s):  
Drug Release ◽  
Angle Of Repose ◽  
Lepidium Sativum ◽  
Disintegration Time ◽  
Natural Sources ◽  
Weight Variation ◽  
Wetting Time ◽  
Tapped Density ◽  
Fast Disintegrating Tablets

ABSTRACTObjective: The main objective of this research was to formulate Fast disintegrating tablets of Flurbiprofen incorporating superdisintegrants, isolated from natural sources like Plantago ovata (PO) seeds, Lepidium sativum (LS) seeds and agar-agar.Methods: Superdisintegrants were isolated from their natural sources using reported methods. Swelling index and hydration capacity was determined for the natural superdisintegrants to know their disintegration capacity. The tablet formulations were designed using isolated natural superdisintegrants. The powder blends were evaluated for pre-compressional parameters like angle of repose, bulk density, tapped density, carr’s index, and hausner’s ratio. Fast disintegrating tablets were prepared by direct compression method. The compressed tablets were characterized for post compression parameters.Results: All formulations had hardness, friability, weight variation and drug content within the pharmacopoeial limits. The wetting time was 84 to 254 sec, in vitro disintegration time was between 59.2 to 221 sec, and in-vitro drug release was as low as 11.80% (LS1) to a maximum of 98.99% (PO4) after 4 min of study. Among all, optimized formulation was PO4, as it showed good wetting time (84 sec), fastest disintegration time (59.2 sec), dispersion time (135 sec) and drug release of 98.99.% within 4 min.Conclusion: Flurbiprofen FDT’s were successfully developed using isolated natural disintegrants. The natural disintegrants isolated showed promising results and can prove as effective alternative for synthetic disintegrants.

scholarly journals FORMULATION AND EVALUATION OF ORAL FAST DISINTEGRATING TABLET OF IBUPROFEN USING TWO SUPER DISINTEGRANTS

2017 ◽  
Vol 9 (4) ◽  
pp. 92
Author(s):  
Hrishav Das Purkayastha ◽  
Bipul Nath
Keyword(s):  
Drug Release ◽  
Magnesium Stearate ◽  
Direct Compression ◽  
Compression Method ◽  
Disintegration Time ◽  
Orally Disintegrating Tablet ◽  
Rapid Release ◽  
Weight Variation ◽  
Fast Disintegrating Tablet

Objective: The aim of the present investigation was to design and evaluate orally disintegrating tablet (ODT) of Ibuprofen, a NSAID drug used for the treatment of arthritis with a view to improve its oral bioavailability. The focus of the current study was to develop ODT of Ibuprofen using super disintegrants for ease of administration and its physicochemical characterization.Methods: Tablets were made from blends by direct compression method. All the ingredients were passed through mesh no. 80. All the ingredients were co-ground in a pestle motor. The resulting blend was lubricated with magnesium stearate and compressed into tablets using the Cadmach single punch (round shaped, 8 mm thick) machine.Results: Physicals parameters of the prepared tablets like Hardness, Weight variation, Friability, thickness, drug content etc. found within the limits. The disintegration time of prepared ODTs was in the range of 45 to 55 seconds. In vitro dispersion time was found to be 22 to 52 seconds which may be attributed to faster uptake of water due to the porous structure formed by super disintegrants. Short disintegration and faster release of ibuprofen were observed with Cross carmellose sodium as compared to sodium starch glycollate.Conclusion: It is concluded that F3 offered the relatively rapid release of Ibuprofen when compared with other formulations. The increase in the concentrations of super disintegrants may lead to increase in the drug release. The formulation prepared with cross carmellose sodium was offered the relatively rapid release of Ibuprofen when compared with other concentrations of both the super disintegrant. 

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