Formulation Of Dosage Forms Research Articles

DETERMINATION OF SOME PHARMACOKINETIC PROPERTIES OF ARTEMETHER-LUMEFANTRINE GRANULES IN ALBINO RATS

Aim and Objectives: Malaria is an infectious disease that is caused by plasmodium parasites which is rampant in Sahara Africa and children under 5 years of age are highly vulnerable to this infection by malaria. So the need for the formulation of dosage form for this population using naturally occurring excipients to replace imported ones being currently used by our local manufacturing industries in-order to formulate novel, readily available, affordable and effective antimalarial medicine for children. Methods: Using the local excipients and its hybrid, the formulated artemether-lumefantrine granules for oral suspension were administered to albino rats, blood samples were collected at predetermined time 0, 1.5, 3, 6, 9, 12, 15, 18, 21, and 24 h respectively and drug contents; artemether-lumefantrine were determined within the stipulated period. Results: Some pharmacokinetic parameters determined were; maximum concentration, Cmax, time to reach the maximum concentration, Tmax, half-life, t1/2, area under the curve, AUC, and mean residence time, MRT, which were for artemether-lumefantrine were 3.9, 3.4, μg/L; 3.2, 6.0 h; 12.5, 14 h; 75.8, 168.5 μg/L.h; 24, 24 h respectively, for the marketed artemether-lumefanthrine granules for oral suspension.4.1, 3.2 μg/L; 1.4, 3.0 h; 3.0, undefined h, 67.0, 65.7 μg/L. h; 18, 18 respectively for hybrid formulated artemether-lumefantrine granules for oral suspension and 3.1, 3.8 μg/L; 2.5, 12.5 h; 4.8, 15 h; 20.2, 281.6 μg/L .h; 18, 18 respectively for the extracted pectin formulated granules. Conclusion: Optimized formulated artemether-lumefantrine granules were superior to the marketed product in terms of pharmacokinetic values being closer to those of earlier workers. Peer Review History: Received 13 May 2024; Reviewed 16 July 2024; Accepted 22 August; Available online 15 September 2024 Academic Editor: Dr. Asia Selman Abdullah, Pharmacy institute, University of Basrah, Iraq, asia_abdullah65@yahoo.com Average Peer review marks at initial stage: 5.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Ahmad Najib, Universitas Muslim Indonesia, Makassar, Indonesia, ahmad.najib@umi.ac.id Dr. Sangeetha Arullappan, Universiti Tunku Abdul Rahman, Malaysia, sangeetha@utar.edu.my

Spectrophotometric determination of celecoxib and tramadol in the new approved formulated dosage form using principle component regression assistive model

Celecoxib and tramadol have been combined in a novel FDA-approved medication to address acute pain disorders requiring opioid treatment when other analgesics proved either intolerable or ineffective. The absorbance spectra of celecoxib and tramadol exhibit significant overlap, posing challenges for their individual quantification. This study introduces a spectrophotometric quantification approach for celecoxib and tramadol using a principle component regression assistive model to assist resolving the overlapped spectra and quantifying both drugs in their binary mixture. The model was constructed by establishing calibration and validation sets for the celecoxib and tramadol mixture, employing a five-level, two-factor experimental design, resulting in 25 samples. Spectral data from these mixtures were measured and preprocessed to eliminate noise in the 200–210 nm range and zero absorbance values in the 290–400 nm range. Consequently, the dataset was streamlined to 81 variables. The predicted concentrations were compared with the known concentrations of celecoxib and tramadol, and the errors in the predictions were evidenced calculating root mean square error of cross-validation and root mean square error of prediction. Validation results demonstrate the efficacy of the models in predicting outcomes; recovery rates approaching 100 % are demonstrated with relative root mean square error of prediction (RRMSEP) values of 0.052 and 0.164 for tramadol and celecoxib, respectively. The selectivity was further evaluated by quantifying celecoxib and tramadol in the presence of potentially interfering drugs. The model demonstrated success in quantifying celecoxib and tramadol in laboratory-prepared tablets, producing metrics consistent with those reported in previously established spectrophotometric methods.

QUANTIFICATION AND QUALITY CONTROL OF TRIPLE-DRUG COMBINATION EMPLOYED FOR GASTRIC ULCER USING STABILITY-INDICATING SELECTIVE RP-HPLC TECHNIQUE

Objective: A seven-day regimen consisting of vonoprazan (VNP), amoxicillin (AXC) and clarithromycin (CRC), administered twice daily, has been permitted and reimbursed by health coverage as initial therapy. No technique has been implemented yet to determine the quantities of VNP, AXC, and CRC combination. This work effectively aimed at estimating these medications (VNP, AXC, and CRC) at the same time by developing an HPLC technique that saves money and time. Methods: The VNP, AXC, and CRC were separated in a “Waters” column (C18 nature; 250 mm sized length; 4.6 mm sized internal diameter; 5 µm sized particle; 25 °C temperature). Phosphoric acid (0.1% in water; pH 4.2) and absolute methanol (50:50, v/v) comprise the mobile phase. The drug product, Voqueznatripak, was subjected to hydrolysis, oxidation, photolysis, and thermal stressors with the intent to cause enforced degradation. The suggested "HPLC conditions" were verified in compliance with ICH guidance. Results: The measurements had a linear range of 10–20 µg/ml for VNP and 250–750 µg/ml for AXC and CRC. The AXC, CRC, and VNP had LOQ’s 5.302 µg/ml, 5.487 µg/ml and 0.523 µg/ml, respectively. Precision measurements were<0.2% RSD and accuracy ranges were 99.40% to 101.46%. The newly devised “HPLC conditions” specificity attribute and stability-indicating quality were also validated by forced degradation tests. Conclusion: The newly devised “HPLC conditions” for analysing AXC, CRC, and VNP in formulation dosage form and stability samples might be adapted by quality control laboratories. The devised “HPLC conditions” is qualified and consistent to reveal and detect any probable change in the drug product assessments throughout stability experiments.

Development and Validation of Fenofibrate in Bulk and Tablets using UV-Spectroscopy: An Anti-Hypercholesterolemic Agent

The spectrophotometry provides versatile techniques for analyse drug in multi component pharmaceutical formulation in presence of various interferences. Simple, accurate, sensitive, precise and rapid UV-Spectrophotometric methods have been developed for the estimation of fenofibrate in bulk and tablet dosage form formulation. To determine the absorption maximum, the drug fenofibrate were scanned in wavelength range of 200-400nm in spectra measurement mode using the double beam UV-Spectrophotometer, 290 nm was selected as a sampling wavelength in DMF as solvent. Beer’s limit was obeyed in the range of 2-10 µg/ml for fenofibrate. The correlation coefficient found to be satisfactory. Validation parameters such as its accuracy, linearity, precision, limit of detection (LOD), and limit of quantitation (LOQ) was studied for proposed method according to the ICH guidelines. Results of all parameters were found to be satisfactory. The proposed method can be used effectively for routine analysis and estimation of fenofibrate in bulk and dosage form. The result demonstrated that the proposed method is accurate, precise and reproducible.

The palm oil-based chlorophyll removal and the evaluation of antiaging properties on Centella asiatica ethanolic extract

Centella asiatica is an essential medicinal herb in numerous traditions. The high chlorophyll concentration of C. asiatica makes dosage form formulation challenging. On the other hand, palm oil is feasible to eliminate the chlorophyll from plant-based products. This research aim to analysis the phytochemical profile and in vitro anti-aging effects on chlorophyll removal of C. asiatica extract. The extract was soxhletated in 70% ethanol. The extract was partitioned with 50% ethanol and palm oil to create a dechlorophyllation extract. Asiaticoside was analyzed using TLC-densitometry. The cytoprotective effect of H2O2-induced oxidative stress in Vero cells was assessed using MTT assays. Flow cytometer analysis was used for quantifying the intracellular ROS. The senescence-associated-β-galactosidase assay was used to identify senescent cells. The efficiency of chlorophyll removal by palm oil was 90.94±0.62%. The dechlorophyllation extract (DE) showed a concentration of 1.58±0.02% for asiaticoside, but it was not found in the original extract (OE). DE significantly reduced H2O2-induced cytotoxicity in Vero cells compared to OE. Both DE and OE reduced intracellular ROS and senescent cells. Palm oil-based chlorophyll removal improved the phytochemical content and anti-aging effects of C. asiatica in ethanolic extract.

Characterization of 2-((4-(chloromethyl)benzoyl)oxy)benzoate acid for analgesic tablet dosage form formulation

The 2-((4-(chloromethyl)benzoyl)oxy)benzoic acid (4CH2Cl) is a potential analgesic compound derived from salicylic acid and 4-chloromethyl benzoyl chloride. Characterization required 4CH2Cl for the formulation of tablet dosage forms. This study aims investigate the effect of SSG, PVP-K30, and the combination of SSG*PVP K-30 on the formulation of 4CH2Cl tablets. Additionally, this study aimed to obtain the optimum 4CH2Cl tablet composition. The experiment followed the two-factor simplex lattice design and direct compression method. The analgesic activity of 4CH2Cl in the optimal tablet was investigated using the hot-plate methods. The ANOVA of linear models is acceptable and the polynomial coefficients of quadratic models are similar to those of linear models. The coefficient of the linear model shows that SSG and PVP K-30 increase the Carr index (16.26; 20.61), Hausner ratio (1.19; 1.29), hardness (4.19; 9.39), friability (0.48; 0.67), disintegration time (0.34; 7.50), and drug release (85.29; 97.69). The coefficient of the quadratic model shows that SSG*PVP K-30 increased the Carr index (1.90), Hausner ratio (0.04), hardness (1.88), friability (0.06), and drug release (4.56), and decreased disintegration time (−0.30). SSG and PVP K-30 increased Carr index, Hausner ratio, hardness, friability, disintegration time, and drug release. The combination of SSG*PVP K-30 has the same effect, except that the disintegration time decreased. The optimum tablet formula is 4CH2Cl (300 mg), Ne (75 mg), SSG (33.60 mg), PVP K-30 (22.40 mg), MCC (40 mg), and SDL (up to 800 mg). 4CH2Cl tablets can be a candidate and choice for new analgesic drugs in the future.

Designing, Creating, and Assessing a Modified Pulsincap Delivery System for Intestine Targeting of Fluvastatin in Accordance with Circadian Rhythm

The current study’s objective remains to create the Pulscap delivery system using an insoluble capsule core that contains fluvastatin sodium microspheres. Eudragit RL 100 polymer fluvastatin sodium microspheres were made using the solvent evaporation method. To reduce the possibility of stomach upset, these microspheres were hand-filled into capsules, plugged with hydrogel plugs, then sealed with ethyl cellulose acetate and dipped in an eight: two (vol/vol) Acetone: ethanol solution by butyl pthalate of (0.75%) and 5% cellulose acetate phthalate solution. Formulated dosage form was assessed for in-vivo X-ray imaging studies, in-vitro drug release studies, and in-vivo imaging studies, pharmacokinetic study of the optimized formulation was conducted in a two-way cross-over design with 6 rabbits in each group and the pharmacokinetic parameters (Cmax, Ka, Ke, MRT and AUC0-α) are measured. A Pharmacodynamics study was also performed on lipid profiles in six groups of rabbits. Optimized formulation (F20) which is prepared with a drug and polymer ratio of 1:3, is selected based on a dissolution study which shows a percentage release of 99.98. ± 0.12% at 17th hour. In the in-vivo study, the plasma concentration at 12th hour 53.8 ± 0.02% and at 32nd hour 13.9 ± 0.05%. Pharmacokinetic parameter Cmax (ng/mL): 53.8 ± 0.41, MRT (h): 20.0 ± 0.14, t1/2 (h): 8.52 ± 0.014, Kel (h-1) :0.08 ± 0.014, Ka (h-1):0.25 ± 0.02, AUC0-a (ng h/mL): 944.9. ± 4.05. Serum lipid profile in high cholesterol rabbit after treatment with F20 formulation total cholesterol:240.83 ± 19.76, HDL-C:37.33 ± 2.16, triglycerides:318.67 ± 7.74, VLDL-C:63.73 ± 1.55, LDL-C:139.77 ± 18.74. Compared to lovastatin SR release, lovastatin pulsatile release, and fluvastatin SR release, the results imply that the F20 formulation’s pulsatile drug delivery has established good drug delivery for medications entering the gastrointestinal tract, and it displays superior pharmacokinetic and pharmacodynamic parameters.

Beneficial Fruit-Derived Phytochemicals in Treating Alzheimer’s Disease – A Review

Fruits, as a major source of nutrition have been investigated for their emerging evidence of several neuroprotective activities beneficial to Alzheimer’s disease (AD). This paper discusses recent evidence suggesting several fruit-derived bioactive substances that possess anti-AD activity. The original articles from 2011–2022 were collected from Pubmed and Scopus with related keywords and filtered. Several fruit constituents have shown significant inhibitory action against β-amyloid and tau hyperphosphorylation, either directly or indirectly via secretase inhibition. Some were also found to be cholinesterase inhibitors with specific antioxidative roles, disruptors of the neuroinflammation system, and promoters of neurogenesis and the neurogenic process. Many fruit phytochemicals remarkably alter the capability defects shown in AD animal models, such as catechin, nobiletin, and alpha-mangostin. Therefore, further investigations exploring a certain bioactive isolate or formulated dosage form and its mechanism of action are necessary to provide effective prevention and supplementary treatment for AD.

Comprehensive Characterization and In vitro Evaluation of a Novel POQCL Drug Delivery System

Aim: Formulation and evaluation of the POQCL drug delivery system. Background: One of the major barriers in the formulation of dosage forms is the poor solubility of the drug. BCS class IV drugs are having a problem with pharmacokinetics or reaching the site of action. Poor water-soluble drugs of BCS class IV obstruct drug bioavailability and decrease their pharmaceutical development. An attempt has been made in this work to deliver the BCS class IV drug into a novel carrier dosage form i.e., liposomes using a novel lipid. Objective: Formulation of the POQCL drug delivery system. Characterization by average particle size, surface morphological analysis, % drug entrapment, drug loading, in vitro study of drug release, and kinetic models of drug release of the prepared POQCL formulation. Methods: POQCL was prepared by emulsification-evaporation technique with some modifications and evaluation was done by average particle size, surface morphological analysis, drug entrapment percentage, drug loading, in vitro study of drug release, and kinetic models of drug release. Results: The average size of particle and surface morphology of prepared POQCL were found to be 76.89 nm and spherical in shape. The percentage yield was found to be 62.5% for the POQCL formulation. The percentages of drug entrapment efficiency and loading capacity were found to be 90% and 47.36% respectively. The drug in vitro release outcomes were 24.27% within the 2 hours and 75.18% within 12 hours and followed the zero-order drug release kinetic model for the POQCL formulation. Conclusion: In this research study, we found that pilu oil is a useful novel lipid source in the formulation of liposome drug delivery for the encapsulation of BCS class IV drugs. POQCL formulation showed optimum average particle size with enhanced entrapment efficiency and drug loading as well as a sustained release of drug was found. In the future, the prepared liposomes of pilu oil may be considered as the choice of drug delivery system for BCS class IV drugs.

The Role of the Geometric Configuration of Diethylaminoethanol Derivative in the Pharmaceutical Development of a Dosage Form Based on It

Introduction. A comprehensive study of the active pharmaceutical ingredient (API) molecule is one of the defining criteria for pharmaceutical development according to the Quality by Design (QbD) concept and the ICH Q8 framework. The spatial arrangement of atoms in the molecule often has a significant impact on the physicochemical and technological properties of API, and hence on the method of producing dosage form based on it.Aim. To study some properties of substances, geometrical isomers of the molecule, which is a derivative of diethylaminoethanol (DEAE), as well as to compare the selected technologies for the preparation of dosage form.Materials and methods. The objects of the study were two substances, spatial isomers of the molecule, a derivative of DEAE, possessing neuroprotective, antiastenic and antioxidant effects. The study of properties of API and the obtained tablets was carried out in accordance with the requirements of the State Pharmacopoeia of the Russian Federation XIV edition, the Pharmacopoeia of the Eurasian Economic Union, as well as the European Pharmacopoeia 9.0 edition. In this research were used substances that have not expired at the time of the study, as well as authorized for medical use.Results and discussion. The geometrical configuration of the DEAE derivative influences the properties of the API, which has an impact on the stages of pharmaceutical development, especially on the development of the technology and formulation of dosage form. The use of cis-DEAE significantly simplifies the technological process and improves the quality of the resulting drug, and as a consequence, better stability and longer shelf life of dosage form may be achieved.Conclusion. In the course of the study, some properties of cis-DEAE API were studied and compared with similar properties of trans-DEAE. A comparison of tablet preparation technologies based on the two mentioned configurations of the DEAE derivative molecule has been carried out. It was found that the isomers have different technological properties and also differ significantly in moisture adsorption capacity. This property determines the approach to tablet preparation. The technology of tablets based on cis-DEAE appears to be simpler, and dosage form based on it is more stable.

Formulation and Evaluation of Orodispersible Tablets of Rizatriptan Benzoate

The major intention of this work is to formulate and evaluate the orodispersible tablets of Rizatriptan benzoate by direct compression technique for the management of migraine. In this work natural superdisintegrants are utilized for rapid disintegration of the formulated dosage form. In addition the natural superdisintegrants were compared for superior effect which was shown by the dehydrated banana powder. The formulation containining banana powder showed the lesser disintegrationt time and higher drug release when compared with the formulations containing mango peel pectin and Gellan gum.

A sensitive UPLC-MS/MS method for the simultaneous assay and trace level genotoxic impurities quantification of SARS-CoV-2 inhibitor-Molnupiravir in its pure and formulation dosage forms using fractional factorial design

Two potential genotoxic impurities were identified (PGTIs)-viz. 4-amino-1-((2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one (PGTI-1), and 1-(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2,4(1H,3H)-one (PGTI-II) in the Molnupiravir (MOPR) synthetic routes. COVID-19 disease was treated with MOPR when mild to moderate symptoms occurred. Two (Q)-SAR methods were used to assess the genotoxicity, and projected results were positive and categorized into Class-3 for both PGTIs. A simple, accurate and highly sensitive ultra-performance liquid chromatography-mass spectrometry (UPLC-MS/MS) method was optimized for the simultaneous quantification of the assay, and these impurities in MOPR drug substance and formulation dosage form. The multiple reaction monitoring (MRM) technique was utilized for the quantification. Prior to the validation study, the UPLC-MS method conditions were optimised using fractional factorial design (FrFD). The optimized Critical Method Parameters (CMPs) include the percentage of Acetonitrile in MP B, Concentration of Formic acid in MP A, Cone Voltage, Capillary Voltage, Collision gas flow and Desolvation temperature were determined from the numerical optimization to be 12.50 %, 0.13 %, 13.6 V, 2.6 kV, 850 L/hr and 375 °C, respectively. The optimized chromatographic separation achieved on Waters Acquity HSS T3 C18 column (100 mm × 2.1 mm, 1.8 µm) in a gradient elution mode with 0.13% formic acid in water and acetonitrile as mobile phases, column temperature kept at 35 °C and flow rate at 0.5 mL/min. The method was successfully validated as per ICH guidelines, and demonstrated excellent linearity over the concentration range of 0.5–10 ppm for both PGTIs. The Pearson correlation coefficient of each impurity and MOPR was found to be higher than 0.999, and the recoveries were in between the range of 94.62 to 104.05% for both PGTIs and 99.10 to 100.25% for MOPR. It is also feasible to utilise this rapid method to quantify MOPR accurately in biological samples.

Zinc(II) complexation strategy for ultra-sensitive fluorimetric estimation of molnupiravir: Applications and greenness evaluation.

The endemicity of the pandemic coronavirus disease 2019 (COVID-19) infection proved to be transitional only. Spikes are forming again in 2023, and high expectations are returning for reinfections and viral mutations. Molnupiravir (MOL) has been approved as an oral antiviral drug for the treatment of the COVID-19 causative virion. Therefore, the development of an ultrasensitive, instantaneous, and cost-effective method for the quantification of MOL in real plasma samples and formulated dosage form are mandatory. The proposed approach is based on the synthesis of a MOL metal-chelation product. MOL as a ligand was chelated with 1.0 mM zinc(II) in an acetate buffer (pH 5.3). After illumination at 340 nm, the intensity of the MOL fluorescence measured at 386 nm was increased by about 10-fold. The linearity range was found to be from 60.0 to 800.0 ng mL-1 with limit of quantitation (LOQ) of 28.6 ng mL-1 . Two methods were utilized for measuring the greenness of the proposed method (Green Analytical Procedure Index [GAPI] and analytical greenness metric [AGREE] methods), with results equal to 0.8. The binding stoichiometry of MOL with the zinc(II) ion was found to be 2:1. All the experimental parameters were optimized and validated using International Conference on Harmonization (ICH) and United States Food and Drug Administration (US-FDA)recommendations. Furthermore, the fluorescent probes were successfully utilized in real human plasma with high percentages of recovery (95.6%-97.1%) without any matrix interferences. The mechanism of fluorescent complex formation was confirmed using 1 H NMR in the presence and absence of Zn(II). The method was further utilized for testing content uniformity of MOL in its marketed capsule dosage forms.

Peningkatan Pengetahuan Masyarakat dengan Pendampingan Formulasi Handsanitizer Standar WHO di Kelurahan Mojosongo, Surakarta

INCREASING PUBLIC KNOWLEDGE WITH ASSISTANCE IN WHO STANDARD HANDSANITIZER FORMULATION IN MOJOSONGO VILLAGE, SURAKARTA. The Applied Pharmacy Research Group has a service roadmap that examines medicinal products, supplements, cosmetic and traditional medicines that can contribute and be adopted by society. One of the issues is liquid dosage form formulation. Alcohol is the one of choice after washing hands with soap. The use of hand sanitizer can deactivate microorganisms that stick to hand. This increase in use because pandemic covid-19 that made many people take preventive action. One way to prevent the spread of the Corona virus is maintain cleanliness such as diligently washing hands with soap and water. In the other hand the use of handsanitizer is also recommended when you cannot reach water and soap. Activity community service in Mojosongo Village, focuses on increasing public knowledge in formulate liquid Handsanitizer that is practical and simple according to the standards requirment by WHO (World Health Organization). The results of the questionnaire conducted before and after assistance in making hand sanitizers stated that most of the respondents had showed an increase in knowledge related to components in the manufacture of handsanitizers

Flaxseed Mucilage Hydrogel based Floating Drug Delivery System: Design and Evaluation

Natural polymer-based plant polysaccharides and proteins have been most widely explored as an adjuvant in the dosage form formulation. Here we design a novel gastro-retentive floating tablet, based on a polysaccharide material from Flaxseed (Linum usitatissimum L.) for Domperidone. After oral administration; Domperidone showed good solubility in acidic pH but significantly reduced solubility in alkaline medium. So that to increase the absorption and bioavailability of Domperidone, it is necessary to increase the retention time in the upper part of the Gastrointestinal tract (GIT) by developing a floating sustained drug delivery system. The directly compressible floating tablets of domperidone were formulated using varying amount of hydroxypropyl methylcellulose K 100 M (HPMC K100 M), Carbopol 934 and Flaxseed mucilage. Hardness, friability, weight variation, thickness, disintegration time of tablet formulations were within acceptable limits. The overall results explained that the optimized formulation F5 prepared by the exact ratio of Flaxseed mucilage, HPMC K100 M, Carbopol, could be more efficient on floating and sustained release of Domperidone in the upper part of GIT as compared to the tablets prepared by using HPMC K100 M and Carbopol 934 only. These findings indicated that Flaxseed can be used to develop novel gastro-retentive sustained release drug delivery system with the double advantage of sustained drug release at the upper part of GIT.

Preparation and Characterization of Pregelatinized Sago Starch (PSS) from Native Sago Starch (NSS) (Metroxylon sp.) and its Evaluation as Tablet Disintegrant and Filler-Binder on Direct Compression Tablet

Starches are biodegradable and relatively inexpensive natural biopolymers which are widely used in the food and pharmaceutical industries. Sago starch is one of the starches which can be potentially used as the excipient in pharmaceutical formulation. The purpose of this study was to modify and to characterize the physical and chemical properties of native sago starch (Metroxylon sp) (NSS) and pregelatinized sago starch (PSS). NSS was evaluated to be confirmed with the requirement, including microscopic analyses, amylum identification, ash content, amylum acidity, loss on drying, solubility in water, solubility in ethanol, and chemical content of Pb, Cd, Hg. Physically evaluated for both types of sago starch were particle size, moisture content, flow rate, angle of repose, tapped density, compactibility, water absorption rate, and water absorption capacity. Fourier transform infrared spectroscopy (FT-IR) was used to characterize and evaluate PSS and NSS’s chemical properties. Chemical content (Pb, Cd, Hg) and microbial content (yeast mold figures, number of bacteria, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella sp., Shigella sp.) of PSS are also identified. The results of this study showed that PSS exhibited different values of those determined parameters compared to that of NSS on particle size, moisture content, flow rate, the angle of repose, tapped density, water absorption rate, and water absorption capacity. In conclusion, PSS has better flow properties because it has a larger particle size than the NSS. PSS also has a larger water absorption rate and water absorption capacity than the NSS because PSS can interact with water easier than NSS. There is no bacterial content in PSS which means PSS follows the regulatory requirement. PSS had a good effect on weight uniformity, hardness, and disintegration time of the tablets. It makes PSS can be potentially used as the excipient in solid dosage form formulation.

Green Atomic Absorption Spectroscopic Methods for the Determination of Rabeprazole Sodium and Fluvastatin Sodium in Pure and Pharmaceutical Dosage Forms

Aims: Novel green analytical methods have been proposed for the assay of Rabeprazole sodium and Fluvastatin sodium in their pure and formulated dosage forms.
 Study Design: The methods determine each drug through the estimation of its sodium content, using Flame Atomic Absorption Spectroscopy at wavelength 589 nm. 
 Place and Duration of Study: Central laboratory at Faculty of Pharmacy, Damanhour University. Time duration January-March, 2020.
 Methodology: Methods are developed and optimized for maximum sensitivity, selectivity and degree of greenness. Linearity is achieved in the range of 8.29- 66.33 ppm of Rabeprazole sodium (equivalent to 0.5- 4 ppm Na) and 14.13- 141.32 ppm of Fluvastatin sodium (equivalent to 0.75 -7.5 ppm Na). The proposed assays are fully validated regarding ICH guidelines. 
 Results: Atomic spectroscopic assays are compared to reported spectrophotometric ones for each drug separately using Student t-test and F-variance ratio. 
 Conclusion: Satisfactory values indicate good agreement and the insignificant difference between both methods. The obtained percentages of recovery (99-101%) indicate no interference from excipients in formulation matrices.

A Study on Extraction and Characterization of Vigna mungo Polymer

The aim of work is to extract and characterize the Vigna mungo polymer solvent using acetone and ethanol. Natural polymers contribution towards formulation of dosage forms is appreciable as they are biocompatible, biodegradable and safe. So extraction and characterization of Vigna mungo polymer helps in the interaction studies of preformulation. In this present study, various physicochemical characters like phytochemical screening, viscosity, particle size analysis, and flow characteristics were determined. Further characterization performed using FTIR and XRD. Vigna mungo polymer obtained using acetone was taken into further studies of evaluation because of more product yield and less particle size. FTIR results revealed existence of carbohydrate nature. X-ray diffractogram presented degree of crystallinity 26.4%. And phytochemical screening of the extracted polymer indicated presence of mucilage and carbohydrates using ruthenium red and molisch's test. Statistical analysis of data was performed using two way ANOVA using Graphpad prism 5 software was used to compare Vigna mungo polymer extracted using acetone and ethanol. Physicochemical parameters experimental data found to be statistical significance two way ANOVA (P < 0.05).

FORMULATION AND EVALUATION OF FAST DISSOLVING TABLET USING LOCUST BEAN GUM AS A NATURAL SUPERDISINTEGRANT AND COMPARISON WITH THE MARKETED PREPARATION

The aim was to formulate and evaluate fast dissolving tablets of diclofenac sodium to improve the bioavailability of the drug and patient compliance. Fast dissolving tablets of diclofenac sodium were prepared by direct compression method by using superdisintegrants (locust bean gum) in 2%, 3%, 4% 5% & 6% concentration respectively. Tablets were formulated by using natural superdisintegrants locust bean gum (LBG). This formulated mixture i.e., drug and LBG was mixed with other excipients and the tablets were compressed by direct compression. Formulated tablets were characterized by FTIR, pre-compression and post-compression parameters. The In vitro drug release studies were performed in pH 6.8 phosphate buffer. Formulated tablets were characterized by FTIR, the results of IR study showed that there was no interaction between superdisintegrant and pure drug, the results of FTIR study showed that drug was stable in the final formulated tablet. The drug content was evaluated with the help of assay. Five (F1-F5) formulations were evaluated for pre-compression and post-compression parameters and all the results were in the standard limits. Formulated dosage form may be an effective alternative to conventional dosage form which can be effectively used in the treatment of inflammation specially in cases of acute pain.

Method Development and Validation of Evening Primrose oil and its Pharmaceutical dosage form by Simple UV- Spectrophotometric Method

In the present work, simple and sensitive UV spectroscopic method has been developed for the quantitative estimation of Evening Primrose Oil in efem capsule. Cyclohexane was used as solvent. In the range of 100-500μg/ml, the linearity of Evening Primrose Oil shows a correlation co-efficient of 0.999. The UV detection wavelength was 233nm. The percentage RSD for precision and accuracy of the method was found to be less than 2%(LOQ) of 23μg/ml and (LOD) of 7.5μg/ml. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Evening Primrose Oil and in formulation dosage form.