scholarly journals Evaluation of Critical Quality Attributes of Immediate Release Ciprofloxacin Tablets of Different Pharmaceutical Companies in Bangladesh

2021 ◽  
Vol 17 (4) ◽  
pp. 781-788
Author(s):  
Paroma Arefin ◽  
Rezvi Ahmed ◽  
Md Shehan Habib ◽  
Sreebash Chandra Bhattacharjee ◽  
Dipankar Chakraborty ◽  
...  
Keyword(s):  
Immediate Release ◽  
Quality Attributes ◽  
Essential Medicines ◽  
World Health ◽  
Physical Parameters ◽  
Pharmaceutical Companies ◽  
Pharmaceutical Dosage Form ◽  
Critical Quality Attributes ◽  
Weight Variation ◽  
Tract Infections

Critical Quality Attributes (CQAs) is an important factor in Pharmaceutical development as it determines the strength, release of the API from SDFs, and stability of a pharmaceutical dosage form. Moreover, substandard and counterfeit drugs have been a major concern in recent days.Ciprofloxacin is a second-generation fluoroquinolone derivative that exerts its effects by inhibiting bacterial DNA gyrase (Topoisomerase II). It is used for the treatment of bacterial gastroenteritis, respiratory tract infections, controlling bronchitis and pneumonia caused by Gram negative bacteria. Ciprofloxacin has been listed in the World Health Organization (WHO) Model list of Essential Medicines. In recent decades, the pharmaceutical industry has been experiencing excellent growth in both local and international market.In our present study, we have analyzed theCritical Quality Attributes (CQAs) including length, thickness, friability, weight variation, hardness test and disintegration time of Ciprofloxacin tablet to study whether the ciprofloxacin immediate release tablets of different pharmaceutical companies available in the Bangladeshi market to assess whether they are compliant to BP or USP guidelines in respect of physical parameters. We have also performed statistical analysis and found that that all the tablets from different brands are within the BP or USP requirements. So, from the study, we reached the conclusion that the critical quality attributes for ciprofloxacin immediate release tablets of different pharmaceutical companies in Bangladesh ensure the appropriateness of their strength, purity, release of the API from SDFs, and stability.

scholarly journals Applications of Statistical Tools for Optimization and Development of Smart Drug Delivery System

2021 ◽  
Author(s):  
Pankaj Sharma
Keyword(s):  
Dosage Form ◽  
Quality By Design ◽  
Process Analytical Technology ◽  
Quality Attributes ◽  
Critical Material ◽  
Statistical Tools ◽  
Pharmaceutical Dosage Form ◽  
Critical Quality Attributes ◽  
Critical Material Attributes ◽  
Form Development

In the novel dosage form development, quality is the key criterion in pharmaceutical industry. The quality by design tools used for development of the quality products with tight specification and rigid process. The specifications of statistical tools are essentially based upon critical process parameters (CPPs), critical material attributes (CMAs), and critical quality attributes (CQAs) for the development of quality products. The application of quality by design in pharmaceutical dosage form development is systematic, requiring multivariate experiments employing process analytical technology (PAT) and other experiments to recognize critical quality attributes depend upon risk assessments (RAs). The quality by design is a modern technique to stabilize the quality of pharmaceutical dosage form. The elements of quality by design such as process analytical techniques, risk assessment, and design of experiment support for assurance of the strategy control for every dosage form with a choice of regular monitoring and enhancement for a quality dosage form. This chapter represents the concepts and applications of the most common screening of designs/experiments, comparative experiments, response surface methodology, and regression analysis. The data collected from the dosage form designing during laboratory experiments, provide the substructure for pivotal or pilot scale development. Statistical tools help not only in understanding and identifying CMAs and CPPs in product designing, but also in comprehension of the role and relationship between these in attaining a target quality. Although, the implementation of statistical approaches in the development of dosage form is strongly recommended.

scholarly journals Study on antibiotic use among geriatric patients based on anatomical therapeutic classification or defined daily dose methodology and world health organization-essential medicine list access, watch and reserve concept in tertiary care hospital of South India

2020 ◽  
Vol 9 (7) ◽  
pp. 1106
Author(s):  
Subash Senthilkumar ◽  
Arun Raaj S. A. ◽  
Padmavathi K. ◽  
Dhanapal C. K. ◽  
Periasamy K.
Keyword(s):  
Geriatric Patients ◽  
Tertiary Care ◽  
Essential Medicine ◽  
Antibiotic Use ◽  
Essential Medicines ◽  
World Health ◽  
Defined Daily Dose ◽  
Care Hospital ◽  
Daily Dose ◽  
Tract Infections

Background: Geriatric patients are more vulnerable to infections and need special consideration on antibiotic use. Resistance to antibiotics among infectious bacteria has developed within a short span. There is a direct correlation between the consumption of antibiotics and the development of resistance. And surprisingly very few literatures were available on antibiotic consumption in geriatric population using defined daily dose (DDD) concept which paved the idea to conduct this study.Methods: A prospective observational study was carried out from November 2018 to April 2019. A total of 206 prescriptions of elderly patients were included in the study. The antibiotics were categorized by anatomical therapeutic classification (ATC) and DDD indicator/1000 inhabitants/day (DID) was used to figure out antibiotic consumption.Results: About 25.2% of patients were treated with antibiotics for respiratory tract infections. The patients received antibiotics empirically (53.8%) and without bacteriological investigation (58.73%). The overall consumption of antibiotics was 20.47 DID in which oral antibiotics was (8.5 DID) 42% and parenteral antibiotics (11.8 DID) 58%. Cephalosporins was observed to be the most consumed antibiotics (33.2%), specifically cefotaxime (14.6%) and ceftriaxone (12.6%). Moreover, 54.4% of antibiotics consumed from watch category of World Health Organisation (WHO) essential medicines list (EML) which was completely against WHO standard proportion.Conclusions: Higher consumption of cephalosporins, which falls into watch category was analysed in geriatric patients. These broad-spectrum antibiotics have high potential to develop antimicrobial resistance. A strict antibiotic policy is needed to be framed that enhance rational prescribing practices in geriatrics.

Formulation and Development of Divalproex Sodium Bi-Layered Tablets using Superdisintegrants and Release Retardant Polymers

2017 ◽  
Vol 10 (2) ◽  
pp. 3669-3675
Author(s):  
Ankit Acharya ◽  
Mohammed Gulzar Ahmed ◽  
Ravi Chaudhari ◽  
Renukaradhya Chitti
Keyword(s):  
Drug Release ◽  
Sustained Release ◽  
In Vitro Release ◽  
Immediate Release ◽  
Physical Parameters ◽  
Content Uniformity ◽  
Divalproex Sodium ◽  
In Vitro Drug Release ◽  
Weight Variation

Divalproex sodium is considered as the most important antiepileptic drug and widely used for treatment of epilepsy and bi-polar disorders and prophylaxis of migraine. The present work has been done to formulate bi-layered tablet of Divalproex sodium containing immediate release layer and sustained release layer. The FTIR study revealed that there was no interaction between drug and polymer and combination. Both layers were prepared by wet granulation technique as poor flow property exhibited by pure drug. The immediate release layer was formulated by using superdisintegrants and evaluated for physical parameters, disintegration time and in vitro drug release. The optimized immediate release layer (IF6) with highest in vitro release of 98.11 was selected for bi-layered tablet formulation. HPMC K4M and HPMC K100M polymer were used to retard the drug release from sustained release layer in different proportion and combination and evaluated for physical parameter along with in vitro drug release studies. The optimized sustained release layer (SF8) which extends the Divalproex sodium release more than 18 hrs was selected. Finally, bi-layered tablets were prepared by double compression of selected sustained release layer and immediate release layer of Divalproex sodium. The tablets were evaluated for hardness, thickness, weight variation, friability, drug content uniformity and in vitro drug release. All the physical parameters were in acceptable limit of pharmacopeial specification. The stability studies, shown the bi-layer tablet was stable at 40oC / 75% RH for a period of 3 months.  

scholarly journals Gliclazide: Biopharmaceutics Characteristics to Discuss the Biowaiver of Immediate and Extended Release Tablets

2020 ◽  
Vol 10 (20) ◽  
pp. 7131
Author(s):  
Bruna de Carvalho Mapa ◽  
Lorena Ulhôa Araújo ◽  
Neila Márcia Silva-Barcellos ◽  
Tamires Guedes Caldeira ◽  
Jacqueline Souza
Keyword(s):  
Extended Release ◽  
Immediate Release ◽  
Pharmacokinetic Profile ◽  
Dosage Forms ◽  
New Drugs ◽  
Essential Medicines ◽  
World Health ◽  
Drug Candidate ◽  
Dissolution Profile ◽  
First Choice

The lists of essential medicines of the World Health Organization (WHO) and Brazil include gliclazide as an alternative to the oral antidiabetic drug of first choice, metformin, in the treatment of type 2 diabetes mellitus because of its pharmacokinetic profile and few side effects. Thus, it is also considered by WHO and the International Pharmaceutical Federation (FIP) as a drug candidate to biowaiver, which is the evaluation of how favorable the biopharmaceutics characteristics are in order to obtain waiver from the relative bioavailability/bioequivalence (RB/BE) studies to register new medicines. This paper presents a review about the solubility, permeability and dissolution of gliclazide. A critical analysis of the information allowed to identify gliclazide as a Biopharmaceutics Classification System (BCS) Class II drug. Therefore, new drugs in immediate release dosage forms will not be eligible for biowaiver. Regarding the extended release dosage forms, besides the limited solubility, no information on the comparative dissolution profile was found, which would be necessary to analyze a possible biowaiver for a smaller dosage. It can be concluded that the registration of new medicines containing gliclazide must undergo RB/BE studies, since there is not enough evidence to recommend the replacement and waiver of such studies for immediate and extended release formulations.

Formulation and Evaluation of Immediate Release Bilayer Tablets of Telmisartan and Hydrochlorothiazide

2011 ◽  
Vol 4 (3) ◽  
pp. 1477-1483
Author(s):  
Natarajan R ◽  
N Patel ◽  
Rajendran N N ◽  
M Rangapriya
Keyword(s):  
Antihypertensive Drugs ◽  
In Vitro Release ◽  
Immediate Release ◽  
Wet Granulation ◽  
Physical Parameters ◽  
Dissolution Profile ◽  
Formulation Development ◽  
Sodium Starch Glycolate ◽  
Bilayer Tablets

The main goal of this study was to develop a stable formulation of antihypertensive drugs telmisartan and hydrochlorothiazide as an immediate-release bilayer tablet and to evaluate the dissolution profile in comparison with a reference product. The formulation development work was initiated with wet granulation. Telmisartan was converted to its sodium salt by dissolving in aqueous solution of sodium hydroxide to improve solubility and drug release. Lactose monohydrate and microcrystalline cellulose were used as diluents. Starch paste is prepared in purified water and was used as the binder. Sodium starch glycolate is added as a disintegrating agent. Magnesium stearate was used as the lubricant. The prepared granules were compressed into a double-layer compression machine. The tablets thus formulated with higher proportion of sodium starch glycolate showed satisfactory physical parameters, and it was found to be stable and in vitro release studies are showed that formulation (F-T5H5) was 101.11% and 99.89% respectively. The formulation T5H5 is further selected and compared with the release profile of the innovator product, and was found to be similar (f2 factor) to that of the marketed product. The results suggest the feasibility of developing bilayer tablets consisting of telmisartan and hydrochlorothiazide for the convenience of patients with hypertension.  

A short review on important drugs under clinical trial against Covid-19

2020 ◽  
Vol 21 ◽  
Author(s):  
Namita Misra
Keyword(s):  
Respiratory Illness ◽  
Short Review ◽  
World Health ◽  
Upper Respiratory Tract ◽  
Suspected Infection ◽  
Medicinal Treatment ◽  
Travel Restrictions ◽  
Personal Level ◽  
Health Organization ◽  
Tract Infections

: Corona virus spreads from one to other person, either by touching the hands or by touching the surface contaminated with this virus, and then touching the nose or mouth. Covid-19 infected human symptoms are like any pneumonia symptoms, dry cough and high fever. Upper respiratory tract infections symptoms and sore throat are rare. First notified in china dated 12th December 2019 as a respiratory illness. In addition to travel restrictions and quarantine measures everyone should follow the World Health Organization advice guidelines on the management of humans infected with known or suspected infection with SARS-CoV-2 virus at the personal level. The development of vaccine or medicines for the same are under progress and this short review will summarize the most potential candidates such as Remdesivir, Lopinavir and Ritonavir, Chloroquine, Hydroxychloroquine, Hydroxychloroquine with Azithromycin, Favipiravir, Umifenovir, and Ribavirin for its medicinal treatment.

Medicinal Chemistry of Alternative Therapeutics: Novelty and Hopes with Genus Ammannia

2019 ◽  
Vol 19 (10) ◽  
pp. 784-794 ◽  
Author(s):  
Harish C. Upadhyay
Keyword(s):  
Traditional Medicine ◽  
Biological Activities ◽  
World Health ◽  
Biologically Relevant ◽  
Traditional Medicines ◽  
Drug Molecules ◽  
Health Organization ◽  
Tract Infections ◽  
Pharmacologically Active ◽  
Herbal Formulations

The plants have formed the basis of folklore remedy since the beginning of human civilization. The cumulative human endeavor and experience over a period of thousands of years developed into well to organize traditional medicine systems viz. Ayurvedic, Unani, Chinese amongst others. Across the world, traditional medicine is either the mainstay of health care or serves as a complement to modern drugs. In view of worldwide use of traditional medicines, World Health Organization launched ‘WHO-Traditional Medicine Strategy 2014-2023’ for the development of strong policies regarding knowledge-base, safety, quality-control and effectiveness of traditional/alternative therapeutics for national health systems. Besides their use in traditional medicine, plants have always been a good source of modern drug/pharmacologically active molecules. More than half of the modern pharmaceuticals are either plant isolates or their derivatives. The plant-based drugs are not only effective, but have better compatibility with human biological systems because of more biologically relevant chemistry, hence lesser side effects. Some of the species of genus Ammannia (Lythraceae) have been reported for their magical medicinal values. Many herbal formulations containing Ammannia spp. have been patented for treatment of serious diseases/disorders like cancer, spinal disease, human female infertility, chronic tonsillitis, pelvic inflammatory disease, treatment of bladder stones, urinary tract infections, dermatitis etc. The uses of Ammannia spp. in traditional medicine have been further verified by the biological activities of their extracts as well as isolation of bioactive phytomolecules. The current review provides details about Ammannia spp.; its use in folklore remedy, herbal formulations, biological activities of extracts, isolation of bioactive phytomolecules and SAR study of semi-synthetic derivatives to analyze the possibility of new drug molecules of plant origin.

Chemistry of Iodinated Contrast Media (ICM): A Minireview

2020 ◽  
Vol 17 ◽  
Author(s):  
Maithili Pramod Joshi ◽  
Ameya Chaudhari ◽  
Prashant S. Kharkar ◽  
Shreerang V. Joshi
Keyword(s):  
Adverse Effects ◽  
Contrast Media ◽  
Aqueous Solubility ◽  
Synthetic Methods ◽  
Essential Medicines ◽  
World Health ◽  
Iodinated Contrast Media ◽  
Environmental Aspects ◽  
Iodinated Contrast ◽  
Health Organization

: Historically, the use of Iodinated Contrast Media (ICM) for diagnostic purposes, particularly radiography and computed tomography (CT), is well-known. Many of the ICM are included in the World Health Organization (WHO)’s List of Essential Medicines. Depending on the chemotype and the presence of ionizable functional group(s), the ICM are categorized in the ionic/nonionic monomers/dimers. The lipophilicity, aqueous solubility, viscosity and osmolality are major characteristics dictating their use for one procedure versus the other. Over last several decades, substantial advancement occurred in the design and development of novel ICM, solely to reduce their propensity to cause adverse effects. Given the nature of their acute usage, some of the agents with appreciable toxicity are still used. Understanding their chemistry aspects is crucial to appreciate, acknowledge and justify the usage of these extremely important torch-bearers of diagnostic agent’s class. The present review article presents an in-depth overview of the synthetic methods, therapeutic indications, potential adverse effects along with the commercial and environmental aspects of ICM. The safety and tolerability of these agents is a field that has gained significant importance, which is given due importance in the discussion.

Design and Optimization of Chronotherapeutic Dosage Form for the Treatment of Angina Pectoris

2020 ◽  
Vol 10 ◽  
Author(s):  
Rupali Singh ◽  
Rishabha Malviya
Keyword(s):  
Drug Delivery ◽  
Angina Pectoris ◽  
Ethyl Cellulose ◽  
Dosage Form ◽  
Cellulose Solution ◽  
Specific Drug ◽  
Pharmaceutical Dosage Form ◽  
Weight Variation ◽  
Short Period ◽  
Time Specific

Background: The chronotherapy concept attains considerable focus towards itself due to its pulsatile fashion rather than continuous delivery. The delivery of the right amount of drug to the target organ at the most appropriate time is fulfilled by using the chronotherapeutic dosage form. Aim: The present study aims to develop and evaluate a chronotherapeutic drug delivery system by using natural polymer for time specific drug delivery at the target site. Material and Method: Tamarind seed polysaccharide was extracted and used in the preparation of core tablets. Nine formulations of core tablets were prepared with nifedipine at 5 tonnes of pressure on 6 mm punch. The core tablets were prepared by using the compression coating method. The three batches F1, F2 and F3 were prepared by using tamarind gum in different concentration i.e. 45%, 22.5% and 67.5% respectively and compressed at 8 tonnes of pressure on 12 mm of punch. The finally compressed tablet was coated with different concentrations of ethyl cellulose in which isopropyl alcohol used as a solvent. In a controlled medium, a stability study was performed to evaluate the physical appearance, drug content and release of the prepared core tablet. Result: All the nine formulations of tablets were prepared successfully and the evaluation studies (thickness, weight variation, hardness, friability etc.) revealed that all the formulations were within the official range. The release study of the drug revealed that the formulation F7 containing 67.5% of tamarind polymer, coated with 2%, 4% and 5% of ethyl cellulose solution released 59.68±1.03% (Q50%) drug within 5 h whereas, 87.09±2.08% (Q80%) within 6 h and within 12 h 97.74±2.19% of the drug was released. The formulation F7 was found to be more effective as it released the maximum amount of drug in a short period as compared with other formulations. Conclusion: The coating of core tablets allowed to prepare pharmaceutical dosage form for time specific drug delivery. These chronotherapeutic core tablets can be used for the treatment of angina pectoris and hypertension etc.

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