scholarly journals CONTROLE DE QUALIDADE DE CÁPSULAS MANIPULADAS CONTENDO ATORVASTATINA CÁLCICA

2020 ◽  
Vol 12 (2) ◽  
pp. 59-69
Author(s):  
Diego da Silva Ribeiro ◽  
Nayra Mendes da Silva ◽  
Ana Julia Pereira Santinho Gomes

Atorvastatin calcium (ATC) is one of the most used drugs in the treatment of dyslipidemia. The compounding of capsules containing ATC has often been requested as it is an exceptionaldispensing drug (continuous use and high cost). ATC presents low solubility and high permeability, therefore, pharmaceutical ingredients are capable of interfering with its solubility. The aim of this work was to evaluate the quality of ATC capsules prepared incompoundingpharmacies in Divinópolis,Brazil.Fourier Transform Infrared spectroscopy (FTIR) was used to identify the ATC. Tests for weight determination (WD), content uniformity (CU) and dissolution were also carried out. The FTIRconfirmed the authenticity of ATC. All batches were approved in relation to the WD, however only 67% were approved in relation to the CU, although all have been approved for acceptance value.It was also observed that 1/3 of the products did not display the specified dissolution rate. This is due to the excipient composition impacting on a significantly slower dissolution profile compared to the others. It was noted that the choice of a specific excipient for ATC together with an appropriate encapsulation procedure play key roles in ensuring the quality of an exceptional dispensing drug, whose dissolution behaviorcan influence oral absorption. In conclusion, the importance of monitoring the compounding process was demonstrated, expanding the relevance of the constant evaluation of the quality of pharmaceutical dosage forms, bringing to light the difficulties of the compounding sector, as well as the effectiveness of the approval criteria employed to date.

Author(s):  
Pawar AR ◽  
◽  
Mehetre JS ◽  

Purpose: The objective of the present study was to formulate solid dispersions (SD) of Atorvastatin calcium to improve the aqueous solubility and dissolution rate to facilitate faster onset of action. Atorvastatin calcium is a lipid lowering agent belonging to BCS-II having low solubility and high permeability.


Author(s):  
Yulias Ninik Windriyati ◽  
Matsniyyatul Badriyah ◽  
Diar Arum Kusumaningtyas ◽  
Rian Lesta Riesmalia

The dissolution of atorvastatin calcium need to be improved since included BCS Class II drugs with low solubility and high permeability, meaning that the dissolution affects the bioavailability of drugs. This research aimed to develop a formulation of a liquisolid tablet using PEG 400 as a solvent and some carrier materials in various compositions to increase the dissolution of atorvastatin calcium. Different formulations of liquisolid tablets were conducted using different quantities of carrier and coating material for adsorbing liquid solvent to produce a free-flowing and compressible powder. Avicel PH 101, Avicel PH 102, Neusilin US2 were employed as the carrier and Aerosil 200 as the coating material. A disintegrant and lubricant were then added to the formed liquisolid system and compressed into tablets by the direct compressing method. The liquisolid tablets were characterized for their tableting properties and possible drug-excipient interaction by XRD and FTIR analysis. The tableting characteristics of atorvastatin calcium liquisolid tablets were within the acceptable limits criteria. The dissolution of AA4 and NA1 liquisolid tablets was higher compared to marketed tablets. Based on the XRD and FTIR analysis, no interactions between drug and excipient.  


2019 ◽  
Author(s):  
Selass Kebede ◽  
Habtamu Abuye ◽  
Woldemichael Abraham ◽  
Sultan Suleman ◽  
Sileshi Belew

AbstractThe safety of medicines is an essential part of patient safety. Global drug safety depends on strong national systems that monitor the development and quality of medicines. Poor quality medicines do not meet official standards for strength, quality, purity, packaging and labelling. Hence, this study determines in-vitro quality attributes of glibenclamide 5mg tablet marketed in Addis Ababa according to USP-38 drug monograph specifications. All tested brands meet the requirements for physical inspection & complied specification for friability and hardness. Besides, the tested brands met USP 38 specification for assay (99.96% to 108.85%) and for content uniformity (AV values ranges from 3.35 to 10.04). In-vitro release tests were carried out in phosphate buffer of 7.5 and 8.5 pH and showed drug release of ≥ 75%, met USP 38 requirements. However, significant difference with respect to dissolution profile among tested brands GL4 and GL6 were confirmed with comparator product through model independent approach. Moreover, DE values were studied and confirmed that GL4 and GL6 were not therapeutically interchangeable with innovator product.


2010 ◽  
Vol 105 (2) ◽  
pp. 421-430 ◽  
Author(s):  
Ece Dilber Gamsiz ◽  
Lee Miller ◽  
Avinash G. Thombre ◽  
Imran Ahmed ◽  
Rebecca Lyn Carrier

Pharmacy ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 96 ◽  
Author(s):  
Md. Islam ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Chisana Uwatoko ◽  
Mohammad Rahman ◽  
...  

Many poor-quality medicines are supplied to patients mainly in developing countries. No systematic survey on counterfeit medicines has been conducted in Myanmar since 1999. The purpose of this study was to investigate the current situation of substandard or counterfeit medicines in Myanmar. Samples of oral medicines, cefuroxime axetil (CXM), donepezil hydrochloride (DN) and omeprazole (OM), and injections, ceftriaxone sodium (CTRX), and gentamicin sulfate (GM), were collected from pharmacies, hospitals, and wholesalers in Yangon, Myanmar in 2014. Authenticity and quality were verified. There were 221 (94%) foreign medicines among 235 collected samples. Five samples of GM and 1 DN sample were not registered with the Food and Drug Administration, Myanmar. In quality analysis, 36 samples out of 177 (20.3%) did not pass quantity tests, 27 samples out of 176 (15.3%) did not pass content uniformity tests, and 23 out of 128 samples (18.0%) did not pass dissolution tests. Three of the unregistered GM samples failed in both identification and microbial assay tests. Counterfeit GM is being sold in Yangon. Also, the quality of OM is a matter of concern. Poor-quality medicines were frequently found among the products of a few manufacturers. Regular surveys to monitor counterfeit and substandard medicines in Myanmar are recommended.


Author(s):  
Rana Obaidat ◽  
Bashar Al-taani ◽  
Hanan Al-quraan

Objective: Meloxicam is classified as class II corresponding to its high permeability and low solubility (12μg/ml). This study aims to compare the effect of selected polymers on stabilization of amorphous form, and dissolution of meloxicam by preparation of different solid dispersions using selected polymers (chitosan oligomers, polyvinylpyrrolidone K30, and polyethylene glycols).Methods: These solid dispersions were prepared using two different methods; solvent evaporation method for the two molecular weights chitosan carriers (16 and 11KDa) and polyvinylpyrrolidone-K30 and melting method for the two different molecular weights polyethylene glycol (4000 and 6000). The physicochemical properties of solid dispersions were analyzed using differential scanning calorimetry, Fourier transform infra-red analysis, Powder X-ray diffraction, and scanning electron microscopy. Selected dispersions were then compared to two selected marketed drugs (Mobic® and Moven®).Results: Best dissolution rates were obtained for both polyvinylpyrrolidone-K30 and polyethylene glycol 6000, followed by chitosan 16 kDa, chitosan 11 kDa, and polyethylene glycol 4000. Increasing polymeric ratio increased dissolution rate except for chitosan. Precipitation of the drug as amorphous form occurred in chitosan and polyvinylpyrrolidone-K30 dispersions, while no change in crystallinity obtained for polyethylene glycol dispersions. Failure of polyvinylpyrrolidone-K30 in the maintenance of stability during storage time was observed while re-crystallization occurred in chitosan-based dispersions, which ends with preferences to polyethylene glycol dispersions. After comparing the release of selected dispersions with the two selected polymers; all dispersions got a higher release than that of the two marketed drugs release.Conclusion: The dissolution profile of meloxicam has been increased successfully in a reproducible manner.


Author(s):  
Ahmed H. Ali ◽  
Shaimaa N. Abd-Alhammid

       Atorvastatin have problem of very slightly aqueous solubility (0.1-1 mg/ml). Nano-suspension is used to enhance it’s of solubility and dissolution profile. The aim of this study is to formulate Atorvastatin as a nano-suspension to enhance its solubility due to increased surface area of exposed for dissolution medium, according to Noyes-Whitney equation.         Thirty one formulae were prepared to evaluate the effect of ; Type of polymer, polymer: drug ratio, speed of homogenization, temperature of preparation and inclusion of co-stabilizer in addition to the primary one; using solvent-anti-solvent precipitation method under high power of ultra-sonication. In this study five types of stabilizers (TPGS, PVP K30, HPMC E5, HPMC E15, and Tween80) were used in three different concentrations 1:1, 1:0.75 and 1:0.5 for preparing of formulations. At the same time, tween80 and sodium lauryl sulphate have been added as a co-stabilizer.          Atorvastatin nano-suspensions were evaluated for particle size, PDI, zeta potential, crystal form and surface morphology. Finally, results of particle size analysis revealed reduced nano-particulate size to 81nm for optimized formula F18 with the enhancement of in-vitro dissolution profile up to 90% compared to 44% percentage cumulative release for the reference Atorvastatin calcium powder in 6.8 phosphate buffer media. Furthermore, saturation solubility of freeze dried Nano suspension showed 3.3, 3.8, and 3.7 folds increments in distilled water, 0.1N Hcl and 6.8 phosphate buffers, respectively. Later, freeze dried powder formulated as hard gelatin capsules and evaluated according to the USP specifications of the drug content and the disintegration time.        As a conclusion; formulation of poorly water soluble Atorvastatin calcium as nano suspension significantly improved the dissolution of the drug and enhances its solubility.


2021 ◽  
Vol 6 (42) ◽  
pp. 223-237
Author(s):  
Nurhafiza Ab Majid ◽  
Shahlan Surat

In line with the current educational revolution, the use of ICT in Teaching and Learning (T&L) is seen as important in improving the quality of learning in schools, especially in private schools in Malaysia. However, without the willingness to maximize the use of ICT, has triggered anxiety, depression, and inner stress among private school teachers. Consequently, this study is conducted in a quantitative survey on 70 private school teachers around Kuala Lumpur, Selangor, and Negeri Sembilan. The results of the study showed that respondents often felt tired after completing T&L sessions with the use of ICT (M = 3.71), often faced health problems such as muscle tension, eye irritation, and headaches with the continuous use of ICT in the T&L session (M = 3.67). Results of Pearson correlation between the relationship of anxiety, depression, and stress with the time of use of the ICT in T&L for a week (r=0.643). Overall, the results of the study showed the level of anxiety, depression, and stress of private school teachers on the use of ICT in T&L is at a moderate level (M = 2.77) and those responsible need to address this problem by developing the standard operating procedures (SOPs) that are appropriate especially regarding the amount of time that should be allocated in the T&L session in a week, to help teachers plan their work-life balance and essential task in school.


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