scholarly journals Post-marketing Assessment of Esomeprazole and Lansoprazole Enteric Coated Products Available in Saudi Arabia Based on Quality Control

2021 ◽  
pp. 94-106
Author(s):  
Doaa Hasan Alshora ◽  
Mohamed Abbas Ibrahim ◽  
Ahmed Mohammed Alomar ◽  
Tahani Nasser Alsufian
Keyword(s):  
Quality Control ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Drug Products ◽  
Relative Standard ◽  
The Us ◽  
Post Marketing ◽  
Generic Products ◽  
Enteric Coated

Introduction: Esomeprazole (ESM) and Lansoprazole (LNZ) are proton pump inhibitors, used in the treatment of peptic ulcer and gastroesophageal reflux disease. Different marketed generic products for both drugs are now available in Saudi market as enteric coated dosage form. Different factors can affect the drug release from enteric coated formulation, and therefore, the final product should be tested. Methodology: In this study three different ESM generic products (20 and 40 mg) and four LNZ generic products (15 and 30 mg) were assessed and compared to the innovator products based on quality control tests. Results: For ESM, it was found that the content uniformity results for the innovator product (Nexium®) and all other generic products lies between 85-115% with relative standard deviation (RSD) less than 6%. Also, the calculated Acceptance values (AV) was less than 15% (L1), which met the US Pharmacopeia. The in-vitro dissolution test in acid stage for Nexium® and other ESM generic products was less than 10% which met the requirement. In case of LNZ, 4 different generic enteric coated pellets filled in capsules were studied and compared to its innovator (Lanzor®), the content uniformity results showed that all products met the requirement with AV less than 15%. The in-vitro dissolution studies showed that all products met the requirement and release less than 10% of the drug in the acidic media, except LNZ-P2 containing both 15 and 30 g LNZ, which exhibited release more than 10% in the acids stage. Conclusion: post-marketing assessments for drug products play an important rule to figure out the non-effective products.

scholarly journals Formulation and In-Vitro Evaluation of Enteric Coated Tablet Incorporating Rabeprazole

2020 ◽  
Vol 10 (2-s) ◽  
pp. 50-57
Author(s):  
Gautam D. Mehetre ◽  
Rameshwar S. Cheke ◽  
Vinayak N. Shrikhande
Keyword(s):  
Drug Release ◽  
Acid Resistance ◽  
Tablet Formulation ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
In Vitro Evaluation ◽  
Enteric Coated Tablet ◽  
Coated Tablet ◽  
Enteric Coated

The objective of the work is to try and assess the applicability and manufacturing possibilities to optimize an enteric coated tablet formulation containing Rabeprazole sodium as the drug aiming at the anti-acidity activity with desired drug release properties. Enteric coated tablet was chosen as dosage form being a cost-effective technology for pharmaceutical industry requiring fewer procedures. Before the implementation of the pharmaceutical technological aims, analysis of critical factors influencing the manufacture was carried out. Reproducible manufacturing processes are required to achieve suitability and tablets uniformity to achieve the uniform properties of tablets, which could influence experimental parameters. Rabeprazole in core content of tablet is blended with HPMC (different grades), xanthan gum, PVPK30, mannitol, crosspovidone, Sodium starch glycolate, Colloidal silicon dioxide to formulate the product. Prepared formulation was tested for weight and content uniformity, physical characteristics, in vitro dissolution behaviour, acid resistance and accelerated stability studies. All studies performed resulted and revealed for assurance of such enteric coated tablet formulation for drug Rabeprazole with optimum characteristics, concluding it as a promising approach to enhance drug release characteristics. Keywords: Rabeprazole, HPMC, enteric coated tablets, In Vitro evaluation.

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

Biopharmaceutical and Preclinical Studies of Zaleplon as Semisolid Dispersions with Self-emulsifying Lipid Surfactants for Oral Delivery

1970 ◽  
Vol 9 (1) ◽  
pp. 3102-3111
Author(s):  
Narendar Dudhipala ◽  
Arjun Narala ◽  
Dinesh Suram ◽  
Karthik Yadav Janga
Keyword(s):  
Oral Delivery ◽  
Molecular State ◽  
In Vivo Studies ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Phase Solubility ◽  
Microscopic Studies ◽  
Pure Drug

The objective of this present study is to develop a semisolid dispersion (SSD) of zaleplon with the aid of self-emulsifying lipid based amphiphilic carriers (TPGS E or Gelucire 44/14) addressing the poor solubility of this drug. A linear relationship between the solubility of drug with respect to increase in the concentration of lipid surfactant in aqueous medium resulting in AL type phase diagram was observed from phase solubility studies. Fusion method was employed to obtain semisolid dispersions (SSD) of zaleplon which showed high content uniformity of drug. The absence of chemical interactions between the pure drug, excipients and formulations were conferred by Fourier transmission infrared spectroscopic examinations. The photographic images from polarized optical microscopic studies revealed the change in crystalline form of drug to amorphous or molecular state. The superior dissolution parameters of zaleplon from SSD over pure crystalline drug interpreted from in vitro dissolution studies envisage the ability of these lipid surfactants as solubility enhancers. Further, the caliber of TPGS E or Gelucire 44/14 in encouraging the GI absorption of drug was evident with the higher human effective permeability coefficient and fraction oral dose of drug absorbed from SSD in situ intestinal permeation study. In conclusion, in vivo studies in Wister rats demonstrated an improvement in the oral bioavailability of zaleplon from SSD over control pure drug suspension suggesting the competence of Gelucire 44/14 and TPGS E as conscientious carriers to augment the dissolution rate limited bioavailability of this active

scholarly journals DESIGN, OPTIMIZATION AND EVALUATION OF CETRIZINE DIHYDROCHLORIDE FAST DISSOLVING FILMS EMPLOYING STARCH TARTRATE–A NOVEL SUPERDISINTEGRANT

2019 ◽  
pp. 75-86
Author(s):  
R. SANTOSH KUMAR ◽  
ANNU KUMARI ◽  
B. KUSUMA LATHA ◽  
PRUDHVI RAJ
Keyword(s):  
Tensile Strength ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Content Uniformity ◽  
Scanning Calorimetry ◽  
Disintegration Time ◽  
Folding Endurance ◽  
Contour Plots ◽  
The Individual

Objective: The aim of the current research is optimization, preparation and evaluation of starch tartrate (novel super disintegrant) and preparation of fast dissolving oral films of cetirizine dihydrochloride by employing starch tartrate. Methods: To check the drug excipient compatibility studies of the selected drug (Cetrizine dihydrochloride) and the prepared excipient i. e starch tartrate, different studies like FTIR (Fourier-transform infrared spectroscopy), DSC (Differential scanning calorimetry) and thin-layer chromatography (TLC) were carried out to find out whether there is any interaction between cetirizine dihydrochloride and starch tartrate. The solvent casting method was used for the preparation of fast dissolving films. The prepared films were then evaluated for thickness, folding endurance, content uniformity, tensile strength, percent elongation, in vitro disintegration time and in-vitro dissolution studies. Response surface plots and contour plots were also plotted to know the individual and combined effect of starch tartrate (A), croscarmellose sodium (B) and crospovidone (C) on disintegration time and drug dissolution efficiency in 10 min (dependent variables). Results: Films of all the formulations are of good quality, smooth and elegant by appearance. Drug content (100±5%), thickness (0.059 mm to 0.061 mm), the weight of films varies from 51.33 to 58.06 mg, folding endurance (52 to 67 times), tensile strength (10.25 to 12.08 N/mm2). Fast dissolving films were found to disintegrate between 34 to 69 sec. Percent dissolved in 5 min were found to be more in F1 formulation which confirms that starch tartrate was effective at 1%. Conclusion: From the research conducted, it was proved that starch tartrate can be used in the formulation of fast dissolving films of cetirizine dihydrochloride. The disintegration time of the films was increased with increase in concentration of super disintegrant.

scholarly journals Automation of dissolution tests

2003 ◽  
Vol 25 (1) ◽  
pp. 7-15 ◽  
Author(s):  
Rolf Rolli
Keyword(s):  
Quality Control ◽  
In Vitro Dissolution ◽  
Pharmaceutical Companies ◽  
Dissolution Testing ◽  
Simultaneous Operation ◽  
Task Forces ◽  
The Core ◽  
Dissolution Tests ◽  
The 1960S

Dissolution testing of drug formulations was introduced in the 1960s and accepted by health regulatory authorities in the 1970s. Since then, the importance of dissolution has grown rapidly as have the number of tests and demands in quality-control laboratories. Recent research works lead to the development of in-vitro dissolution tests as replacements for human and animal bioequivalence studies. For many years, a lot of time and effort has been invested in automation of dissolution tests. There have been a number of in-house solutions from pharmaceutical companies and many have created task forces or even departments to develop automation. Robotic solutions with sequential operation were introduced as well as the simultaneous operation concept developed by SOTAX. Today, pharmaceutical companies focus their resources mainly on the core business and in-house engineering solutions that are very difficult to justify. Therefore, it is important to know the basic considerations in order to plan an automation concept and implement it together with a vendor.

scholarly journals Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products

2018 ◽  
Vol 113 ◽  
pp. 18-28 ◽  
Author(s):  
Sitaram P. Velaga ◽  
Jelena Djuris ◽  
Sandra Cvijic ◽  
Stavroula Rozou ◽  
Paola Russo ◽  
...  
Keyword(s):  
In Vitro Dissolution ◽  
Dry Powder Inhalers ◽  
Dry Powder ◽  
Drug Products

scholarly journals DEVELOPMENT AND EVALUATION OF NOVEL ESTIMATION TECHNIQUES FOR IN VITRO DISSOLUTION STUDY AND VALIDATION PROTOCOL FOR ESCITALOPRAM AS ANTIDEPRESSANT DRUG AND THEIR FORMULATION

2020 ◽  
pp. 55-61
Author(s):  
SHRIRAM H. BAIRAGI ◽  
R. S. GHOSH
Keyword(s):  
Limit Of Detection ◽  
Antidepressant Drug ◽  
Correlation Factor ◽  
In Vitro Dissolution ◽  
Linear Calibration ◽  
Limit Of Quantification ◽  
Minimum Concentration ◽  
Dissolution Study ◽  
Relative Standard

Objective: To develop and validate the RP-HPLC method and in vitro dissolution study for escitalopram as antidepressant drug and their formulation. Methods: The chromatographic separation was done by using a C-18, 150 mm column and a mobile phase consisting of phosphate buffer (40%) and acetonitrile HPLC grade (60%). Detection was carried out at 211 nm with a flow rate of 1 ml/min with an injection of 20 μl. The method was validated with different parameters such as linearity, precision, accuracy, robustness, and limit of detection (LOD), the limit of quantification (LOQ) according to ICH guidelines. Results: The linear calibration curve was obtained in the concentration range of 0-50 μg/ml and gave an average correlation factor 0.992. The retention time was observed at 2.96 min. The Minimum concentration level at which the analyte can be reliably detected (LOD) and quantified (LOQ) were found to be 0.03 and 0.09 µg/ml, respectively. The relative standard deviation of intra and the inter-day assay was found to be less than 2. The dissolution studies show moderate dissolution (23.4%) after 45 min, but it reaches a plateau after approximately 25 min. Conclusion: This method was found to be simple, rapid and economic with less run time. The validated parameters manifest the method is reliable, linear, accurate and precise as well as robust with minor variations in chromatographic parameters. Therefore, the developed method can be applied for both routine analysis and quality control assay and it could be a very powerful tool to investigate the stability of escitalopram.

Comparison of Simvastatin Tablets from the US and International Markets Obtained via the Internet

2008 ◽  
Vol 42 (5) ◽  
pp. 613-620 ◽  
Author(s):  
Michael A Veronin ◽  
Nga T Nguyen
Keyword(s):  
Prescription Drugs ◽  
Web Sites ◽  
High Performance ◽  
International Markets ◽  
The Internet ◽  
Content Uniformity ◽  
Innovator Product ◽  
Drug Products ◽  
Weight Variation ◽  
The Us

Background: Convenient access to prescription drugs produced outside the US has been facilitated by the Internet. Of greatest concern to clinicians and policy-makers is product quality and patient safety. The Food and Drug Administration has issued warnings to potential buyers that the safety of drugs purchased through the Internet cannot be guaranteed and may present consumers with a health risk from substandard products. Objective: To determine whether generic simvastatin tablets and capsules obtained via the Internet from international markets are equivalent to the US innovator product regarding major aspects of pharmaceutical quality. Methods: Twenty simvastatin tablets and capsules were obtained for pharmaceutical analysis: 19 generic samples from international Internet pharmacy Web sites and the US innovator product. Tablet samples were tested according to US Pbarmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. These tests are often used to detect formulation defects of drug products during the manufacturing process. Results: Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution and 2 for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization. Conclusions: Results suggest that manufacturing standards for the international generic drug products compared with the US innovator product are not equivalent with regard to quality attributes. These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet.

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®.

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