International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Client Characteristics and Satisfaction with the Quality of Primary Health Care Centers Services in Babylon Governorate, Iraq
Zahraa A. Khairullah, Buthaina A. Rashid, Raheem S. Shwiehk
Background: Health care service quality plays a crucial role in patient satisfaction and is also one of the most significant quality improvement steps. Objectives: 1. To assess client’s satisfaction towards the efficiency of primary health care centers services in Babylon Governorate. 2. To the assessment of client’s satisfaction with the infrastructure of primary health care centers. 3. To find out the association between total satisfaction score and language expression emoji for clients. Subjects and Method: This is a descriptive, cross-sectional study conducted at 23 randomly selected (multistage sampling technique) primary health care centers in Babylon governorate. Data were collected during the period extended (December 2020 to March 2021) using a questionnaire to assess the client’s satisfaction with the service and use of the direct method of interview (face to face), which lasts for 20–25 minutes. The descriptive statistical data analysis approach (SPSS-27) includes frequencies, percentages, mean of scores, range (minimum-maximum values) approach that includes Chi-square test. Result: The current study was conducted on 460 clients with age groups ranging from 18–63 years, and the highest percentage (47%) were from the 20–29 years age group with an age group 32.8 ± 11.2. While highest percentage 30.2% from a level of education clients primary school graduation, but (40.9%) housewife’s occupation. With regard to the social situation, the majority of the sample are married and represent 355 (77.2%) of the entire sample. The overall satisfaction to health care services delivered was unsatisfied at percent were 49.6%. Conclusions: According to the present findings, the study concluded that the client’s satisfaction score reveals 175 (38.0%) who reviews primary health care centers in Babylon Governorate were satisfied to some extent regarding the efficiency of primary health care centers services and unsatisfied regarding infrastructure.

2. Development and Validation of a Stability-Indicating Reversed-Phase High-Performance Liquid Chromatography Method for Elagolix Sodium using Quality by Design Approach
Pradip P. Todkar, Purnima D. Hamrapurkar
This study developed a stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of elagolix sodium of the bulk drug by using a quality by design (QbD) approach. In a QbD approach, Box-Behnken screening is based on critical method parameters, i.e., initial % acetonitrile (ACN), column temperature, and flow rate. The interaction effect of this parameter [retention time, number of theoretical plates (NTP), and tailing factor] was evaluated in 3D response graphs. The plots revealed the final chromatographic conditions of the method. The present paper describes a new, simple, precise, accurate, and development for estimation of elagolix sodium by the RP-HPLC method. The described chromatographic method was standardized using a C18 column (Inertsil ODS-3 C18 column 250 × 4.6 mm, 5 μ) with gradient elution and mobile phase containing 0.05% trifluoroacetic acid:acetonitrile (55:45 v/v) at a flow rate of 1 mL/min. The eluents were detected by the photo-diode array (PDA) detector at 275 nm. The linearity study of elagolix sodium was found in the concentration range of 1 to 3 μg/mL, and the correlation coefficient (r2) was found to be 0.9992%. The developed method was successfully applied to the bulk drug, as well as, successfully applied for forced degradation studies. Forced degradation studies, include acid hydrolysis, base hydrolysis, oxidation, thermal degradation, and photolytic degradation of elagolix sodium.

3. Formulation of Generic Atorvastatin Calcium Tablet by Reverse Engineering Technique
Furquan N. Khan, Mirza S. Baig, Girish Nihalani, Mohammed Imran, Nikita Deshingkar
The present study involves preparing a generic dosage form of Atorvastatin calcium and establishing the similarity profile with the reference product. It involves a complete study of innovators’ products from literature. Excipients from reference products were separated using differential solubility techniques as different excipients are soluble in different solvents. The study on reverse engineering of Atorvastatin calcium tablets was done using the marketed dosage form of 40 mg strength from the local market. The solvents used for separation were methanol, ethanol, dichloromethane, benzene, water, etc. The quantities of the drug and excipients present in the marketed dosage form after performing reverse engineering are lactose 22.33, MCC 11, croscarmellose sodium 0.55 mg, magnesium stearate 0.2 mg, calcium carbonate 4.2 mg, and drug 0.39 mg. DSC analyzes the separated API, and the results indicated a glass transition temperature of 140°C, and degradation was seen as a decrease in baseline at 190°C. The powder X-ray diffractogram indicated that the drug is X-ray amorphous. The separated excipients and drug were characterized by interpretation of Fourier-transform infrared spectroscopy (FTIR) spectra and melting point determination. Finally, the generic form was prepared, and it is characterized by performing different physical and chemical tests; finally, F2 value in dissolution was determined and was found to be 57.14.

4. Pharmacognosy and Quality Control Analysis of “Berberis aristata
Rahul Sharma, Sanjeev Sharma, Gaurav Sharma
Berberis aristata is commonly known as “Darut haldi” and “chitra” family Berberidacea. The stem is nearly cylindrical, surface rough, and color yellow, plant contains different types of alkaloids, including berbamine, berberine, oxycanthine, epiberberine, palmative, dehydrocaroline jatrorrhizine and columbamine, karachine, dehydrokarachin, etc. The major alkaloid was isolated from B. aristata is berberine having a yield of 2.23%. According to references, therapeutic use of B. aristata is diaphoretic, laxative, and helpful in rheumatism. Fruits, stem, bark, and root have been used in ethno-medicine and many Ayurvedic preparations for several medicinal properties. Organoleptic observation, pH value, alcohol/ water soluble extractive value, water-soluble ash, acid insoluble ash, total ash, and Phytochemical Screening: TLC was done according to guidelines or procedures drafted, by CCRAS and AYUSH. Value obtains from pharmacognosy and quality control analysis of B. aristata was matched with reference pharmacopeia value. It indicates that the collected sample was authentic and standardized.

5. Clinico-epidemiological Study of Behcet’s Disease in Baghdad Teaching Hospital, Baghdad, Iraq
Barq W. Azeez, Atta A. H. Al-Sarray, Ali H. Al-Hafidh
Background: Behcet’s disease is a chronic inflammatory condition marked by major symptoms such as oral aphthous ulcers, uveitis, skin lesions, and genital ulcers. Objectives: To determine the different Clinico-epidemiological features associated with Behcet’s disease patients and find out relationships between the demographical characteristics with epidemiological & clinical characteristics in Baghdad teaching hospital, Iraq. Patients and Methods: A cross-sectional study was conducted, and performed study was in the Rheumatology unit & Dermatology and Venereology center in Baghdad teaching hospital, included (116) patients during the period of 6 months starting on 2nd of November 2019 ending to 2nd of April 2020. Results: The age range at the time of the study was between 13–64 years. The mean age and SD were 35.08 ± 10.46 and 70.7% male while 29.3% female. Regarding the general clinical manifestation of Behcet’s disease were Recurrent oral ulceration, Recurrent genital ulceration, Eye lesion, Skin lesion, Joint symptoms, with higher frequency (96.6%, 37.9%, 67.2%, 62.1%, 75.9%), respectively. Regarding the complication of Behcet’s disease were ocular complications with higher frequency (34.5%), and the first major symptom of BD (94%) was an oral ulcer. The onset of disease at (20–29) years with higher frequency (38.8%). Conclusion: Ocular manifestations high a significant association with severity of disease & duration of disease. A significant association was found between gender with occupation & smoking.

6. Taxonomy, Ontogenesis, Biochemical Composition, and Biological Activity of Hypericum scabrum L. (Hypericaceae Juss.): An Overview
Zaichikova S.G., Ars Yu.V., Bokov D.O., Shchepochkina O.Yu., Antsyshkina A.M., Kovaleva T.Yu.
This review aims to provide updated and generalized data on ethnobotany, ontogeny, phytochemistry, and biological activity of Hypericum scabrum L. This plant has long been used as a medicinal plant in traditional medicine in Turkey and Iran and the republics of the Caucasus and Central Asian region, but not presented in official medicine. Essential oils, terpenoids, flavonoids, anthraquinones (hypericin and pseudohypericin), hyperforin, and other compounds were determined during the phytochemical analysis of this species. An overview of the content and distribution of specific biomarker compounds (i.e., those suspected of being relevant to the pharmaceutical industry) and studies of extracts and individual isolated compounds is presented. Medicinal plant raw materials possess high bioavailability, the absence of toxicity, a wide range of biological activity, and high therapeutic potential. Further study of H. scabrum L. is required to include it in the list of medicinal plant species of official medicine and determine its prospects as a source of modern herbal drugs.

7. In-Depth Investigation of Analytical Methods for the Determination of Bempedoic Acid and Ezetimibe in Biological Fluid and Pharmaceutical Dosage Form: A Review
Anisha I. Kadiwala, Pinkal H. Patel, Gunosindhu Chakraborthy
Bempedoic acid is a new agent which reduces cholesterol synthesis. It is also influenced by fatty acid synthesis, low-density lipoprotein cholesterol (LDL-C). In early trials, it was well tolerated without major side effects. Alone or in many combinations with Ezetimibe, Bempedoic acid lowers levels of non–high-density lipoprotein cholesterol. The Bempedoic acid and Ezetimibe fixed-dose combination significantly lowered low-density lipoprotein cholesterol versus placebo or other oral monotherapies and had a favorable safety profile when added to maximally tolerated statin therapy in patients with hypercholesterolemia and high Cardiovascular Read more at (CV). As a result, fixed-dose combinations of hypolipidemic agents may provide an attractive option for hypercholesterolemia’s effective and safe management. Controlled clinical studies successfully showed a consistent relationship between LDL-C and cardiovascular risk reduction, such that lipid-lowering therapy became a cornerstone in CV risk reduction.

8. Development and Validation of Stability-indicating Method for the Estimation of Cilnidipine, Olmesartan Medoxomil and Chlorthalidone by Reverse Phase High Performance Liquid Chromatography
Kondeti H. Pavani, Dannana G. Sankar
A new combination of Cilnidipine, Olmesartan medoxomil, and Chlorthalidone is used to treat high blood pressure (hypertension), which helps in preventing strokes, heart attacks, and kidney problems. Reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of CIL, OLM, and CHL in the pharmaceutical dosage form. Chromatography was carried out using Agilent C18 150x 4.6, 5.0 mm column with a flow rate of 0.9 mL/min. The mobile phase consisted of pH 3.0, 0.01 N Potassium dihydrogen phosphate buffer, and Acetonitrile in the ratio of 60:40. The retention times of CIL, OLM, and CHL were found to be 2.056, 2.434 and 2.926 minutes, respectively. The method obeys Beer’s law in the concentration range of 2.5–15 μg/mL (R2 = 0.999) for CIL, 10–60 μg/mL (R2 = 0.999) for OLM, and 3.125–18.75 μg/mL (R2 = 0.999) for CHL. The Limit of Detection (LoD) and Limit of Quantitation (LoQ) were found to be 0.7 μg/mL and 2.21 μg/mL for CIL, 0.84 μg/mL and 2.53 μg/mL for OLM and 0.9 μg/mL and 2.72 μg/mL for CHL, respectively. The method’s accuracy was assessed by a recovery study in the dosage form at three concentration levels. The mean % recovery obtained was100.02% for CIL, 99.67% for OLM, and 104.25% for CHL. The content of CIL, OLM, and CHL per tablet was calculated. The method developed has been statistically validated according to ICH guidelines. The method showed good reproducibility and recovery with % RSD less than 2. Forced degradation studies established the stability-indicating capability of the method under stress conditions like acid, base, peroxide, UV, thermal, humidity. Hence, the chromatographic method developed for the estimation was rapid, simple, specific, sensitive, precise, accurate, robust, and reliable that can be effectively applied for routine analysis in research institutions and quality control departments in industries.

9. Treatment Modalities and Comorbidities among Samples of Rheumatoid Arthritis in Baghdad Teaching Hospital, Baghdad, Iraq
Tabarek A. Noori, Atta A. M. Al-Sarray, Ali H. Al-Hafidh
Background: Rheumatoid arthritis (RA) is a systemic inflammatory disorder that most commonly affects the joints, causing progressive, symmetric, erosive destruction of cartilage, and bone. Objectives: To determine the association between comorbidities and treatment patterns (Disease-modifying antirheumatic drugs-DMARDs & biological therapy) in RA patients attending Baghdad teaching hospital, Iraq Subjects and Methods: A descriptive; cross-sectional study conducted at Baghdad teaching hospital in Baghdad city (convenient sample) included 210 patients already diagnosed with RA. The data collection continued for the period starting on 1st December–2020 ending on 1st April 2021. Results: Mean of the age of the studied sample was (50.81 years ± 11 SD), duration of disease (12.7 ± 8.2 SD) they were more frequently women 173 (82.4%), were married (80%), employed (20%), had primary education (38.6%) and (10.48%) smokers. The age group 50–59 years has the highest prevalence of RA (31.4%). Combination use of DMARDs and biological was reported in (94.3%) of the patients, while only (5.7%) of them use biological therapy without DMARDs. Methotrexate was the most common drug used by patients as a DMARD; it was used by (90%) of patients while other types in decreasing of frequency as a follow: Hydroxychloroquine (23.8%); Leflunomide (10.9%); sulfasalazine (1.4%). The mean duration of DMARDs use was (7.6 ± 5.7 yr.). Different biological therapy is available in Iraq. The majority of patients on antitumor necrosis factors (86.7%) while only (13.3%) of them use rituximab. The mean duration of biological use was (4.2 ± 2.5 yr.). Switching among biological drugs was observed in (35.2%) of patients. A significant association was reported between respiratory diseases and receiving biological therapies (Rituximab & TNF- Antagonist) at P-value = 0.005. Also, a significant association was detected between ischemic heart disease (IHD) and biological therapy (P.V= 0.003). Conclusions: Rituximab was used more commonly in rheumatoid arthritis patients with interstitial lung diseases.

10. Potential of “Tar Clean” in the Treatment of Air Pollution Related Disorders
Randhir Singh, Krishan D. Arora, Manisha Arora, Harjinder Singh
Air pollution is considered a significant factor responsible for many diseases related to the respiratory system. Several toxic chemicals are present in polluted air, leading to asthma, COPD, and several types of lung cancer. Among these pollutants, Tar, which is present in the air and cigarette smoke, is responsible for lung cancer and other respiratory disorders. Although several medicaments are available to treat respiratory disorders, herbal drugs are gaining much attention these days. In Ayurveda and ancient literature, several drugs are mentioned to treat respiratory diseases. Among these herbals, Glycyrrhiza glabra, Ocimum sanctum, curcuma longa, Phyllanthus emblica, Terminalia chebula, Terminalia Bellirica, Allium sativum, Rabia cardifolia, Piper nigrum, Zingiber officinale, Piper longum, Cinnamomen Zeylenicum, Vitis vinifera, Sea Backthorn, Abies Webbiana, Cassia fistula, and Piper cubica were found to have significant potential in the treatment of respiratory diseases. One such product named “Tar Clean” by Le-Vanza food and Herbals is available in Indian markets. In this formulation, 19 herbal drugs are present, and these drugs have significant activity against Tar and other pollution-related respiratory disorders. Based on the constituents present in “Tar Clean,” this review has been designed to explain the potential of “Tar Clean” in the management of disorders due to air pollution

11. Comparative Study on Therapeutic Effect of Wheat Germ Oil and Sesame Oil with Some Lipid-lowering Drugs in Local Male Rabbits with Hyperlipidemia, induced by Triton x-100: Physiological and Histological Study
Sura S. A. Ali, Muneef S. A. Al-Janabi
Hyperlipidemia is a heterogeneous group of disorders characterized by excess fat in the bloodstream, and it is considered the primary mediator of a cascade of atherosclerosis. Also, hyperlipidemia is associated with cardiovascular diseases (CVD), including coronary heart disease and stroke, and is one of the leading causes of mortality in developed and developing countries. The present study aimed to identify the therapeutic effect of wheat germ oil and sesame oil on induced hyperlipidemia by triton X-100 and compare their effect with Atorvastatin and Rosuvastatin on some biochemical parameters in local male rabbit serum, which included estimation of lipid profile levels (cholesterol, triglycerides, low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), High-density lipoprotein (HDL), HDL-C, LDL-C, VLDL-C) and lipid peroxidation marker – Malondialdehyde (MDA); in addition to the histological effects of wheat germ oil, sesame oil, Atorvastatin and Rosuvastatin on Aorta tissues.

12. A Possible Warning for COVID-19 Patients on Complications of Fungal Infection: A Review
Neeran O. Jasim
New problems are emerging in the health sector as the global Coronavirus Disease 2019 (COVID-19) pandemic expands worldwide. The big global emergency is the need for effective testing tools, therapies, and vaccines for COVID-19. Although these targets are particularly important, the increasing risk of coinfections is a significant threat to health systems and patients’ lives. Although statistical data are still not adequately released, coinfections in patients with COVID-19 developed secondary systemic mycosis. Any of these significant results will be discussed in this review with the main objective of warning the population of the high risk of concomitant systemic mycosis in individuals with COVID-19 induced weakness. 

13. Adsorption of Amoxicillin onto Graphene Oxide Poly (carboxymethyl cellulose -co-acrylic acid) Hydrogel: Isotherm and thermodynamic studies
Masar A. Awad, Layth S. Jasim
In the present study, graphene oxide/Poly (carboxymethyl cellulose -co-acrylic acid), GO / P (CMC-co-AA) Hydrogel is synthesized by a free radical polymerization and is applied for the adsorption of Amoxicillin (AMX) from aqueous media. To investigate the structure of GO /Poly (CMC-co-AA), Hydrogel, FTIR, FESEM analysis are applied. The effects of pH and contact time on AMX adsorption are studied. The adsorption isotherms of amoxicillin on the GO/P(CMC-co-AA) composite could be illustrated well by the Freundlich and Langmuir model. According to the results of equilibrium data, it was shown that a maximum adsorption capacity of 12.486 mg/g with Langmuir isotherm was the predominant model, and adsorption was a monolayer. Thermodynamic studies also reveal that the adsorption process is exothermic.

14. COVID-19 Knowledge of Health Care Workers in Mosul city, Iraq
Fahad M. M. Taqi, Atta A. M. Al-Sarray, Ali H. Al- Hafith
Background: In December 2019, new coronavirus-induced pneumonia (SARS-CoV-2) appeared in Wuhan, China, and since then has spread quickly everywhere in the world. Objectives: To determine the level of knowledge of Health care workers regarding COVID-19 in Mosul city. Subjects and Methods: A descriptive, cross-sectional study was performed at 28 hospitals and health care centers randomly selected (multistage sampling) in Mosul city, including 517 healthcare workers. Results of demographic data of HCWs: the age range was between 22–63 years, The Mean ± SD of the ages was 39.5 ± 9.9, the highest percentage of ages (38.9%) that was in the age group 30–39 years and the lowest percentage (16.2%) was in the group 20–29 years. The percentage of males in a sample was (52.8%), and females were (47.2%). Relating educational qualification, the highest percentage (46.8%) was from diploma, whereas the lowest percentage (18.8%) was from secondary school. Concerning occupational level, the majority of them were from Paramedical staff (44.5%). The highest percentage regarding years of experience was (61.5%) for those who had equal or greater than 11 years of experience. The most sample of HCWs (82.8%) was married. Conclusion: This study concluded that the most significant proportion of the study sample had an acceptable knowledge score during the study period.

15. Forensic Mycology: Fungal Evidences in Forensic Analysis: A review
Neeran O. Jasim
This is an overview of forensic fungi. It depends on what was mentioned in the references, provides principles information about fungi, and a detailing of the value of fungi in this field, and may achieve effective use of fungi in the forensic analysis. These involved: Provide a tracking guide; post-mortem estimation; Finding the give rise to death, hallucination, or poisoning; determine the place of buried bodies. Previous work was evaluated by taking into consideration the important points that these works contained and their value to display in the tribunal. Situations in which mycology might assist in the investigation were identified in a concise form and presented issues related to the development of the topic.


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