International Journal of Pharmacy and Pharmacology ISSN 2326-7267 Vol. 14 (5), pp. 001-005, May, 2025. Available online at www.internationalscholarsjournals.org © International Scholars Journals
Full Length Research Paper
Comparative Bioavailability of Celecoxib Formulations in Healthy Males: A Randomized Crossover Study
Muhammad Akhtar1*, Mahmood Ahmad1, Irshad Ahmad1, Naveed Akhtar1, Asad Ullah Madni1, Muhammad Usman1, Muhammad Naeem Aamir1, Sonia Khiljee1, Mohammad Sualeh2, Shujaat Ali Khan3 and Muhammad Aleem4
1Faculty of Pharmacy and Alternative Medicine, the Islamia University of Bahawalpur, Pakistan.
2Faculty of Pharmacy, Federal Urdu University, Karachi, Pakistan.
3Department of Pharmaceutical Sciences, COMSATS Institute of Information Technology, Abbottabad, Pakistan.
4Department of Statistics, the Islamia University of Bahawalpur, Pakistan.
Accepted 7 October, 2024
The purpose of this study was to assess bioequivalence of two marketed formulations of celecoxib capsules in healthy human male volunteers. The study was conducted according to a single dose, randomized sequence, open label, two-period and crossover design. Both test and reference formulations comprised labeled dose of 200 mg celecoxib and were administered to each subject after an overnight fasting on two treatment days separated by one week of washout period. After drug administration, blood samples were collected at predetermined time points for a period of 48 h. Plasma separated from blood was analyzed for celecoxib concentrations using validated reverse phase-high performance liquid chromatographic (RP-HPLC) method. Various pharmacokinetic parameters including Cmax, Tmax, AUC0-t, AUC0-∞, T1/2 and Kel were determined from the plasma concentration for both formulations. Cmax, AUC0-t and AUC0-∞, were evaluated for bioequivalence after log-transformation of data. The 90% confidence intervals for the ratio of Cm ax (93.26 to 100.70%), AUC0-t (87.00 to 117.50%) and AUC0-∞ (86.49 to 118.56%), values for the test and reference products were within the acceptance range of 80 to 125%, proposed by Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA). Based on these statistical inferences, it was concluded that two formulations of celecoxib are bioequivalent in their rate and extent of absorption.
Key words: Celecoxib, pharmacokinetics, bioequivalence, healthy human male volunteers.
International Journal of Pharmacy and Pharmacology ISSN 2326-7267 Vol. 14 (5), pp. 001-008, May, 2025. Available online at www.internationalscholarsjournals.org © International Scholars Journals
Full Length Research Paper
Development and Biopharmaceutical Assessment of Fast Dissolving Nifedipine-Cyclodextrin Tablets
Saleh A. Al-Suwayeh1*, Jia-You Fang1,2, Ibrahim M. El-Bagory1,3, Ehab I. Taha1 and Mohsen A. Bayomi1,3
1College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
2Pharmaceutics Laboratory, Graduate Institute of Natural Products, Chang Gung University, Kweishan, Taoyuan,
Taiwan.
3Center of Excellence in Biotechnology Research, King Saud University, Box 2460 Riyadh 11451, Saudi Arabia.
Accepted 11 March, 2025
In this study, nifedipine tablets were formulated with different types of cyclodextrins (CDs) by direct compression method. Spray dried lactose and microcrystalline cellulose (MCC) were used as tablet fillers. The prepared tablets showed good appearance with acceptable crushing strength and disintegration time. The tablets showed fast dissolution within 11 to 68 min for 80% of the drugs depending on the type of CD and tablet filler. Some of the formulated tablets presented good fast release properties similar to soft gelatin capsules (USP XXIV) and based on the calculated dissolution efficiency (DE%), tablets containing hydroxypropyl- -CD and lactose as a filler were chosen for in vivo study by oral administration to beagle dogs when compared with the commercially available 10 mg soft gelatin capsule (Adalat®) and 10 mg film coated tablets (Corinfar ®). The formulated tablets showed significantly higher area under the curve (AUC0- ) than the commercial soft gelatin capsule and film coated tablets as result of increased drug absorption. It was concluded that the formulated fast release tablets could replace the nifedipine soft gelatin capsules with the advantages of ease of preparation and less restricted storage and handling conditions.
Key words: Nifedipine tablets, cyclodextrins, bioavailability, beagle dogs.
International Journal of Pharmacy and Pharmacology ISSN 2326-7267 Vol. 14 (5), pp. 001-009, May, 2025. Available online at www.internationalscholarsjournals.org © International Scholars Journals
Full Length Research Paper
Determination of Acetylator Status in Pakistani Population: A Study of Sulphamethazine Metabolism in Male and Female Volunteers
Naheed Akhter, Tahira Iqbal* and Amer Amil
Department of Chemistry and Biochemistry, University of Agriculture, Faisalabad, Pakistan.
Accepted 09 January, 2025
The acetylation polymorphism is one of the most common inherited variations in the biotransformation of drugs and chemicals and large number of studies has been done to determine the distribution of acetylator phenotypes among populations of different geographic origin. The aim of this study was to investigate the acetylator phenotypes of the Pakistani population and compare it between male and female healthy volunteers. The polymorphic acetylation of sulphamethazine has been investigated in male and female volunteers (50 each) of Pakistani population. Sulphamethazine was administered orally in Capsule form as 500 mg to each healthy male and female volunteer. Sulphamethazine and acetylsulphamethazine were determined in the six hour plasma samples by high-pressure liquid chromatography (HPLC). Acetylator phenotype was determined from the metabolic ratio of acetylsulphamethazine to sulphamethazine in the plasma samples. The acetylation of sulphamethazine by arylamine N-acetyltransferase 2 (NAT2) showed bimodal population frequency distribution. 60% of the female volunteers were found to be fast and 40% to be slow acetylators while that of male volunteers were 62% fast and 38% slow acetylators.
Key words: NAT2 acetylation phenotype, sulphamethazine, male & female volunteers, HPLC assay.
International Journal of Pharmacy and Pharmacology ISSN 2326-7267 Vol. 14 (5), pp. 001-007, May, 2025. Available online at www.internationalscholarsjournals.org © International Scholars Journals
Full Length Research Paper
Antimicrobial Prescribing Practices in Otorhinolaryngology: A Tertiary Care Hospital Study
Farhan Ahmad Khan1*, Sheikh Nizamuddin2 and Mohammad Tariq Salman3
1Department of Pharmacology, Teerthanker Mahaveer Medical College and Research Centre,
Moradabad-244001, India.
2Department of Ear Nose and Throat (ENT), Teerthanker Mahaveer Medical College and Research Centre,
Moradabad-244001, India.
3Department of Pharmacology, Era's Lucknow Medical College, Sarfarazganj, Hardoi Road, Lucknow.-226003. India.
Accepted 12 September, 2024
The objective of this research is to study the pattern of antimicrobial prescription in outpatient (OPD) and inpatient (IPD) of the Department of Otolaryngology in a tertiary care teaching hospital of North India. This was a prospective study conducted at the Teerthanker Mahaveer Medical College and Research Centre, over a period of 12 months. All the patients who attended the Ear Nose and Throat (ENT) OPD and IPD were included. The results show that out of 4800 patients, only 54% (n=2600) of patients were included in the study on the basis of inclusion and exclusion criteria and 31.25 % (n=1500) were defaulters. Majority of the patients were male 60% (n = 1560). Majority of the patients had suffered from ear disorders, 55% (n=1430). The most frequently prescribed antibacterials were - Lactams (75.68%) followed by aminoglycosides (9.43%). Among the penicillin group, the commonest drug prescribed was a combination of amoxicillin and clavulanic acid (9.58%), in cephalosporins was cefixime (37.98%) and in aminoglycosides was gentamicin (6.25%). In the concomitant medications antihistaminic were prescribed in 11.53%, proton pump inhibitors in 20.38% cases and NSAIDS in 7.26% cases. The average number of drugs used in each prescription was 2.70. All the drugs were prescribed with trade names. The average cost per prescription per day in OPD and IPD patients were Rs.45 and Rs.185, respectively. Out of 2600 patients; culture sensitivity tests were performed for only 71 patients (inclusive of OPD and IPD). Of which only 43 patients depicted a positive culture sensitivity tests. Our study showed that antimicrobials were mostly prescribed in patients of ear diseases while it was least in throat disorders. Proton pump inhibitors were the most common concomitant drug used. The cost of treatment in IPD patients were 4.11 times more than the OPD patients.
Key words: Antibacterial agents, drug utilization, ear nose and throat (ENT) infections, prescribing pattern, pharmacoepidemiology.
