Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 17th World Drug Delivery Summit Philadelphia, USA.

Day 1 :

  • Drug Delivery Technologies
Speaker
Biography:

Dr. Sherif Ashraf Fahmy his Ph. D. in Chemistry from the American University in Cairo in collaboration with the Department of Pharmaceutics & Biopharmaceutics, Faculty of Pharmacy, Philipps-Universität Marburg, Germany. He was selected as one of the first recipients of the prestigious fellowship offered by the Alfi Foundation for Ph.D. students. He has received several other awards, most notably, the Royal Society of Chemistry (RSC, UK) Travel Grant for Early Career Scientists in 2019, the Fulbright Scholarship at Ohio University (2019), USA. Dr. Fahmy has published several peer-reviewed articles in international journals and many abstracts at international conferences. He is a member of the Royal Society of Chemistry (MRSC) and the American Chemical Society (ACS). Also, he serves as a reviewer for many international journals. Dr. Fahmy is a full-time Assistant Professor of Chemistry and Head of the Nanomedicine & Phytochemicals research group at the University of Hertfordshire, Egypt Campus

Abstract:

Wound healing is a major healthcare concern, and complicated wounds may lead to severe outcomes such as septicemia and amputations. To date, management choices are limited, which warrants the search for new potent wound healing agents. Natural products loaded in poly (lactic-co-glycolic acid) (PLGA) coated with chitosan (CS) constitute a promising antibacterial wound healing formulation. In this work, harmala alkaloid-rich fraction (HARF) loaded into PLGA nanoparticles coated with chitosan (H/CS/PLGA NPs) were designed using the emulsion-solvent evaporation method. Optimization of the formulation variables (HARF: PLGA and CS: PLGA weight ratios, sonication time) was performed using the 33 Box–Behnken design (BBD). The optimal NPs were characterized using transmission electron microscopy (TEM) and Attenuated Total Reflection Fourier-Transformed Infrared Spectroscopy (ATR-FTIR). The prepared NPs had an average particle size of 202.27 ± 2.44 nm, a PDI of 0.23 ± 0.01, a zeta potential of 9.22 ± 0.94 mV, and an entrapment efficiency of 86.77 ± 4.18%. In vitro drug release experiments showed a biphasic pattern where an initial burst of 82.50 ± 0.20% took place in the first 2 h, which increased to 87.50 ± 0.50% over 72 h. The designed optimal H/CS/PLGA NPs exerted high antibacterial activity against Staphylococcus aureus and Escherichia coli (MIC of 0.125 and 0.06 mg/mL, respectively) compared to unloaded HARF (MIC of 0.50 mg/mL). The prepared nanoparticles were found to be biocompatible when tested on human skin fibroblasts. Moreover, the wound closure percentage after 24 h of applying H/CS/PLGA NPs was found to be 94.4 ± 8.0%, compared to free HARF and blank NPs (68.20 ± 5.10 and 50.50 ± 9.40%, respectively). In conclusion, the three components of the developed nanoformulation (PLGA, chitosan, and HARF) have synergistic antibacterial and wound healing properties for the management of infected wounds.

 

Speaker
Biography:

I am, Mr. Tesfaye Zerihun , graduated in Chemistry Diploma from Kotebe teaching college on JUN, 2006 and Bachelor of pharmacy on July 2011 from Addis Ababa University
I am employed at Addis Ababa university aklilu Lema institution of path biology Research center on September 2007 as Technical Assistance and served for the past 5 years. Giving Technical support for Master and PhD students both on the field and Laboratory.
Currently, I am working as a chief Pharmacist at Addis Ababa University, college of Health Science, Black lion specialized Teaching Hospital in Mentoring under graduate pharmacy students who are coming to the hospital for clinical attachment both at the ward and dispensary area. I am also participating in some of Clinical research which is under go in the Hospital beside the routine work.
 

Abstract:

Objective: To evaluate antileishmanial activity of methanolic extract of Aloe otallensis (A. otallensis) on the promastigote stage of Leishmania donovani (L. donovani) as compared to standard drugs and to screen its phytochemical constituents.
Methods: Phytochemical screening was done by using the method mentioned by Evans and Trease on methanolic extract of the exudates of Aloe otallensis leaves. The extract was also evaluated for in vitro antileishmanial activity against L. donavani which is found from the Parasitology Unit of Black Lion Hospital. The result was compared to standard drugs of sodium stibogluconate, milfostin and paramomycin.
Results: The extract has a good antileishmanial activity with an IC50 of 0.123 0 μg/mL on L. donovani (AM 563). The experimental data showed that relatively it had better activity than paramomycin and milfostin but less activity than sodium stibogluconate. The data analyses were done by GraphPad Prism version 5 software after it was read by ELISA reader at the wave length of 650 nm. The phytochemical screening of the exudates of A. otallensis showed the presence of phenol, alkaloid and saponin.
Conclusions: The methanol extract of the exudates of A.otallensis has a good anti- leishmaniasis activity and this may be attributed to phenol, alkaloid and saponin present in the plant. But it needs further analysis for the conformation of which constituent presents in high concentration to know which one has the strongest effect.

Speaker
Biography:

Tamrat Balcha has his expertise in Table Preparation, development of excipients such as tablet disintegrants and direct compression tablet filler-binders. His experience in the central composite design for optimization of formulation and process variables in the drug delivery systems is immense. He has more than 6 years of teaching experience in pharmaceutics.

 

Abstract:

Background. Tablets are still the most preferred means of drug delivery. The search for new and improved direct compression tablet excipients is an area of research focus. This is because the direct compression method overcomes the drawbacks of granulation methods of tablet production. It exempts several treatment steps associated with the granulation methods. The requirements for the powders to be directly compressible include flowability, low friction tendency, compressibility, and fast disintegration capacity. Taro Boloso-I is a new variety of Colocasia esculenta (L. Schott) yielding 67% more than a previously reported variety (Godare) in Ethiopia. This study is aimed at enhancing the flowability while keeping the compressibility and compactibility of the pregelatinized Taro Boloso-I starch. Methods. Central composite design was used for the optimization of two factors which were the temperature and duration of pregelatinization against 4 responses. The responses were angle of repose, Hausner’s ratio, Heckel’s yield pressure, and tablet breaking force. Results and Discussions. An increase in the temperature resulted in decrease in both the angle of repose and the Hausner ratio and that of time decreased angle of repose as well. The Heckel yield pressure was observed to increase with increasing levels of both temperature and time. The pregelatinized starch prepared by heating 15% slurry of Taro Boloso-I starch at the pregelatinization temperature of 66.22°C for 20 min showed desired flow property and compressibility. Conclusions. Pregelatinized Taro Boloso-I starch could be regarded as a potential direct compression excipient in terms of flowability, compressibility, and compactibility. The PGTBIS could perform better as filler and binder in direct compression tablets than the Starch 1500® in terms of compactibility.

 

  • Routes of Drug Administration
Speaker
Biography:

Abstract:

Background: Malaria is a major cause of morbidity and mortality in the developing countries. Appropriate use of recommended antimalarial drugs is vital in the effective management of malaria. Rational use of antimalarial drugs reduces the development of drug resistance and cost of therapy. Anti-malaria agents have been used for the management of malaria infections over the years in Ethiopia. However, not much is known about the quality of its use.

Objectives: To evaluate the rational use of anti-malarial Drugs on the Management of Malaria Cases and the Rational Prescribing Practice of Antimalarial in Mizan Tepi University hospital, south west Ethiopia.

Methodology: A 1-year retrospective cross-sectional study (chart review) was conducted from July1- to July30/2021. Charts (Data) of 125 patients were reviewed on socio-demographics, rational use of anti-malarial agents as per 2021, guidelines and outcomes.

Results and discussion: A total of 125 patients treated with the Antimalaria drug were reviewed. Of these, 65 (52%) were female. Ninety-one (72.8%) of the subjects belonged to 15 years and older age group. Laboratory test was requested for, 64(51.2%) patients. Forty-five patients were positive for malaria. Twenty-five patients had Plasmodium falciparum following Plasmodium vivax (n=18), and two patients had co-infection. Uncomplicated malaria cases were 15 (12%) whereas 9(7.2%) cases were severe malaria. Artemisinin – Lumefantrine was the most prescribed antimalarial drugs, 70(49.65%) following Artesunate and Chloroquine were, 36(25.53%) and 35(24.82%) respectively. Weight for those properly diagnosed and had severed malaria before Artesunate injection administered was recorded only for 3 (50%) patients. Seven of the patients have not taken single dose of Primaquine despite national malaria treatment guideline recommendation. Even though weight based was appropriate, more than two-third of the patients (82 (65.6 %)) were treated without weight measurement. Four of the patients had taken Primaquine daily for 14 days. Hemoglobin measurement with in the recommended days was not checked for those who were taking Primaquine.

Conclusion: Only 45 confirmed malaria cases among treated 125 patients. Treating patients with Antimalaria drugs irrespective of causative agent was common. Problem of adherence to malaria treatment guideline was observed. Intervention on irrational antimalarial drug use in MTUTH needs concern.

 

  • Advanced Drug Delivery Systems

Session Introduction

Rajendran (Raj) Arunagiri

Global Pharma Segment Manager, Eastman, TN, USA

Title: New excipient to formulate poorly soluble APIs
Speaker
Biography:

Rajendran (Raj) Arunagiri is the Global Pharma Segment Manager at Eastman. Raj has nearly a decade of experience in the pharma industry interfacing with the entire pharma value chain across the globe. Raj’s expertise is understanding global drug delivery trends. Raj has an Electrical Engineering degree from India and an MBA from USA.

Abstract:

One of the toughest challenges facing the drug development today is poor solubility of the API. It is estimated that 70%+ of the APIs in drug development pipeline are poorly soluble in water. There are several approaches to this problem with many requiring processes such as spray drying and hot melt extrusion, complex manufacturing processes. Through our presentation we would like to introduce a new tool to formulate poor water-soluble APIs without the need for spray drying or hot melt extrusion. Through this talk we would like to present our formulation studies with several poorly soluble API. Our dataset for the presentation will include mechanism of action, dissolution, stability, and bioavailability. The presentation will also highlight the formulations of two examples APIs (Aprepitant and Tacrolimus) for the case study. We will also demonstrate the safety of the new excipient and share recently approved reference drug. While not the main topic, we will also demonstrate how this new tool enables the formulation of long acting injectable without the need for any implants

  • Drug repurposing to treat Viruses: COVID-19
Speaker
Biography:

Alpana Bastikar is a computational chemist and bioinformatician in the field of computer aided drug design and bioinformatics industry. Highly well versed with all the licensed computational softwares and also having experience in preparing dossiers for Europe and other countries. She Is Diligent and resourceful professional with excellent analytical and communication skills. She is exceedingly motivated, Methodical and well organized in work culture. She Is a strong team player possessing skillful leadership potentials. 

 

Abstract:

Coronavirus pandemic COVID 19 has caused a wide range of harm worldwide with its inception in December 2019 in Wuhan, China. To date there is no promising drug identified for the treatment of disease. In the view of this, scientists have elucidated X-ray structures of the proteins in SARS-COV2 virus. These can act as probable drug targets for the designing of drugs what is urgent need. One of the main proteins of the virus is its main protease M pro which is responsible for producing polyproteins of the virus. In this study we have used main protease as the target for drug design and repurposing for COVID-19. Two approaches were applied in order to develop a fast and effective treatment against the virus. The first approach was drug repurposing through in-silico docking analysis of existing FDA approved drugs and the second approach was high throughput screening of molecules from the ZINC database against main protease. Two docking protocols-a fast docking algorithm to screen the hits or lead molecules and simulation based molecular dynamics docking procedure to optimize the obtained hits were utilized. We could observe a definite scaffold based binding affinity against the main protease. These scaffolds were lutein, steroids, morphine and quinolone, CPT. Thiotepa was identified as the best docked molecule with highest binding affinity. Unique molecules like lutein, beta carotene, Buprenorphine etc were identified as promising hits which can be used as repurposed drugs against SARS-COV2. Also these scaffolds show unique pharmacophores that can be utilized to design potential novel leads against

 

  • others
Speaker
Biography:

Sabu Thomas is currently the Vice-Chancellor of Mahatma Gandhi University, Kottayam, Kerala, India. He is a Professor at the International and Inter University Centre for Nanoscience and Nanotechnology and Full Professor of Polymer Science and Engineering at the School of Chemical Sciences of Mahatma Gandhi University, Kottayam, Kerala, India. His ground-breaking research has covered the areas of polymer science and engineering, polymer nanocomposites, elastomers, polymer blends, interpenetrating polymer networks, polymer membranes, green composites and nanocomposites, nanomedicine and green nanotechnology. Prof. Thomas has received several national and international awards in recognition for his work, and recently received Honoris Causa (DSc) from the University of South Brittany, Lorient, France, in recognition for his contributions to polymer science and engineering. Prof. Thomas has published over 1400 peer- reviewed research papers, reviews and book chapters. He has co-edited more than 200 books. Currently he is having a H index of 133 with  86000 citations

Abstract:

Green chemistry started for the search of benign methods for the development of nanoparticles from nature and  their use in the field of  antibacterial, antioxidant, and antitumor applications. Bio wastes are eco-friendly starting materials to produce typical nanoparticles with well-defined chemical composition, size, and morphology. Cellulose, starch, chitin and chitosan are the most abundant biopolymers around the world.   Cellulose nanoparticles (fibers, crystals and whiskers) can be extracted from agrowaste resources. Chitin is the second most abundant biopolymer after cellulose, it is a characteristic component of the cell walls of fungi, the exoskeletons of arthropods and nanoparticles of chitin (fibers, whiskers) can be extracted from shrimp and crab shells.  Starch nano particles can be extracted from tapioca and potato wastes. These nanoparticles can be converted into smart and functional biomaterials by functionalization through chemical modifications due to presence of large amount of hydroxyl group on the surface. The preparation of these nanoparticles includes both series of chemical as well as mechanical treatments; crushing, grinding, alkali, bleaching and acid treatments. Since large quantities of bio wastes are produced annually, further utilization of cellulose, starch  and chitins as functionalized materials is very much desired. The cellulose, starch  and chitin nano particles are currently obtained as aqueous suspensions which are used as reinforcing additives for high performance environment-friendly biodegradable polymer materials. These nanocomposites are being used as   biomedical composites for drug/gene delivery, nano scaffolds in tissue engineering and cosmetic orthodontics. The reinforcing effect of these nanoparticles results from the formation of a percolating network based on hydrogen bonding forces. The incorporation of these nano particles in several bio-based polymers have been discussed. The role of nano particle dispersion, distribution, interfacial adhesion and orientation on the properties of the ecofriendly bio nanocomposites have been carefully evaluated.

 

Speaker
Biography:

Sanad Alonezi received his Bachelor’s Degree in Pharmaceutical Sciences from KSU in 2003 and MSc from KSU, Saudi Arabia. He holds PhD in Pharmaceutical Sciences from university of Strathclyde in 2017 (UK). He is a consultant pharmacist at PSMMC. He has a strong interest in areas of research involve metabolomics.

Abstract:

The phenotype microarray (PM) technique provide a high-throughput for characterization the phenotyping of cells. This technique use a redox dye, employing cell respiration (NADH production) as a universal cell based reporter. The dyes used in Biolog assays measure output of NADH production from different catabolic pathways present in the cells being tested. Figure 1. shows the layout of the carbon sources in the PM-M1 microplate. PM method applied to examine the effect of cisplatin, a chemotherapy drug, treatment on the metabolic rate in lung cancer cells produced by different substrates. The H1299 and A549 human lung cancer cell lines were tested by using standard protocols for metabolic PM mammalian cell assays. Dye reduction was calculated from A590-A750 values measured from microplate wells after 6 h from addition of MA dye. Paired t tests from univariate analysis were adjusted. In H1299 cells, there was a reduction in metabolism of dextrin, maltotriose, D-maltose, D-glucose-1-phosphate, and inosine (Figure 2) following treatment with cisplatin. In A549 cells, there was also a reduction in metabolism of substrates such as D-trehalose, D-glucose-6-phosphate and D-glucose-1-phosphate (Figure 3). The uridine, pyruvic acid and ketoglutaric acid were metabolised significantly in A549 cells after treatment with cisplatin in comparison with H1299 cells (Figure 2, 3). Adenosine substrate in the phenotype microarray plate do not appear to be useful as carbon sources in both cells. Treatment of the lung cancer cells with cisplatin produced a different effect on the H1299 cells in comparison with the A549 cells. There was more reduction in carbon metabolism in H1299 cells, but in the A549 cells the metabolism was not that strongly affected and the cells continued to produce NADH. Therefore, there may be differences in the mechanisms by which the two types of lung cancer cells respond to cisplatin treatment, which could lead to different mechanisms of cell death induced by the anticancer activity. The mechanism of necrosis and other cell death pathways may have significant difference between human lung cancer cell lines.

Biography:

Dorcas Akinloye Department of Biochemistry, College of Biosciences, Federal University of Agriculture, Abeokuta, Nigeria
Keywords: Ficus exasperata, dysfunction, Rats, NF-kB, TNF-α

 

Abstract:

The study aims to investigate the protective effects of Ficus exasperata n-hexane ethyl acetate extract against carbon tetrachloride (CClâ‚„)-induced tissue damage in female Wistar rats; using specific activities of alkaline phosphatase (ALP), gamma-glutamyl-transferase (GGT), and 5’ nucleotidase (5’NTDase) along with relative gene expression of nuclear factor-kappa B (NF-kB) and tumor necrosis factor-alpha (TNF-α) as indices. Thirty-six female Wistar rats were divided into six groups (A, B, C, D, E, F) of six rats per group. First, groups A and B were pre-treated with olive oil. Next, groups C, D, E, and F were pre-treated with Vitamin E (100 mg/ kilogram bodyweight (kg bwt)), extract (100 mg/ kg bwt), extract (200 mg/ kg bwt), and extract (200 mg/ kg bwt) respectively for fourteen days. Then, CClâ‚„  single dose injection (intraperitoneally) was given to rats in groups B, C, D, and E. Ficus exasperata n-hexane ethyl acetate extract pre-treatment was able to protect against CClâ‚„-induced toxicity by preventing the overexpression of NF-kB and TNF-α  gene levels along with protection of membrane-bound (ALP, GGT, and 5’NTDase) enzymes linkages into the serum. In conclusion, Ficus exasperata n-hexane ethyl acetate extract could be used to prevent or manage inflammation and membrane dysfunctions.

Speaker
Biography:

Sonakshi is from Las Vegas, Nevada, and just recently graduated from Vanderbilt with a major in Medicine, Health, and Society and a minor in Business and Computer Science. She hopes to pursue a degree in medicine. At Vanderbilt, she worked as an undergraduate research assistant in a surgical transplant lab, helping out with long-term mechanical cardiopulmonary support experiments. In her free time, she loves listening to music, watching Netflix, and she has recently taken up playing the drums.

Abstract:

Alzheimer's Disease (AD), the most common form of dementia, gradually impairs an individual's memory and cognitive abilities. The disease slowly diminishes an individual's ability to carry out daily activities, affecting their behavior, personality, and language skills. Though Alzheimer's most commonly occurs in the later stages of life, it can impact people as early as their 40s. Alzheimer's is characterized by both beta-amyloid plaques and protein tangles composed of phosphorylated tau. Beta-amyloid plaques are caused by accumulations of the protein beta-amyloid, which can occur when the mechanisms that typically break down beta-amyloid protein malfunctions. P-Tau Protein tangles arise when the normal, healthy tau protein becomes phosphorylated, detaching from microtubules and aggregating into tangles that disrupt the normal functioning of nerve cells. As such a devastating disease, researchers have discovered treatments, such as investigational Drug XXX and Drug YYY (both remove amyloid plaques in the brain, preventing AD progression). Multiple ongoing trials are currently studying the effectiveness of the monoclonal antibody investigational drug ZZZ at removing the p-tau protein tangles in the brain, which has shown promising effects in slowing the cognitive and functional decline in patients diagnosed with AD. However, the prevention of AD has yet to be previously studied. Despite the groundbreaking discoveries in AD treatments, there is no way for the brain damage done by the protein plaques or tangles to be reversed: the patients' memories cannot be restored. This study aims to investigate whether the current drug –Drug ZZZ– used to clear out p-tau protein tangles in patients diagnosed with AD would be able to clear out p-tau protein in participants with preclinical AD. By effectively preventing any brain damage caused by the p-tau tangles, we could avoid or at least delay the onset of Alzheimer's Disease.

Biography:

Dra Ana Belén Moldes is Associate Professor in the Chemical Engineering Department of the University of Vigo with more than 20 years of experience in the field of production, extraction and evaluation of biocompounds of microbial origin. Her main scientific contributions focus on the use of Bacillus strains to produce biosurfactants and other bioactive compounds including Gramicidin promoting a circular economy. During her research career she has participated in more than 20 research projects, and she has published over130 articles in JCR journals (most of them Q1 and Q2). The last project aims the sustainable production of Gramicidin. She has an h-index of 38 (Scopus ID: 6603511495), has co-authored 8 patents, has presented over 160 communications at congresses and has co-supervised 8 PhD Theses

Abstract:

Based on previous studies, in this work a complex drug extract produced by Aneurinibacillus aneurinilyticus is analyzed in terms of composition with the aim to study its potential interest for including it on pharmacological formulations. Methodology & Theoretical Orientation: The complex drug was extracted from A. aneurinilyticus cells growth in Tryptic Soy Broth (TSB) using phosphate buffer saline solution (PBS) followed by a dialysis process and lyophilization to remove water and salts respectively. Following the extract was analyzed by Matrix Assisted Laser Desorption/Ionization-Mass (MALDI-TOF) and Fourier Transform Infrared Spectroscopy (FTIR). Commercial Gramicidin and Surfactin (lipopeptide produced by Bacillus subtillis) were used as controls. Findings: It was observed that it is possible to obtain, from A. aneurinilyticus cells, a complex drug extract composed by Gramicidin and lipopeptides, being Gramicidin S, the predominant form of Gramicidin molecules detected in the microbial complex extract. Figure 1 shows a A. aneurinilyticus colony. Probably lipopeptides production by A. aneurinilyticus is related to the production of Gramicidin. Therefore, lipopeptides could promote the excretion of antibiotics to the extracellular media. Conclusion & Significance: Based on the results showed in this work and the microbial coexistence of Gramicidin and lipopeptides in the extracts produced by A. aneurinilyticus it should be interesting to carried out pharmaceutical assays based on Gramicidin where synthetic solubilizing and carrier agents are replaced by lipopeptides. It could be expected that lipopeptides increases the permeation and efficacy of drugs in comparison with non-natural carrier agents.

Biography:

Dr. José M. Cruz Associate Professor in the Chemical Engineering Department of the University of Vigo with more than 20 years of experience in the field of production, extraction and evaluation of biocompounds of microbial origin. His main scientific contributions focus on the use of Bacillus strains to produce biosurfactants and other bioactive compounds including Gramicidin promoting a circular economy. During his research career he has participated in over 40 research projects, he has published during his research career over140 articles in JCR journals (79 Q1). He has an h-index of 42 (Scopus ID: 7402505903), has co-authored 9 patents, has published 13 book chapters, presented over 200 communications at congresses and has co-supervised 9 PhD Theses.

Abstract:

Usually, pharmaceutical active ingredients, like antibiotics are composed by synthetic or microbial compounds that sometimes are combined to obtain the desire effect. However occasionally the pharmacological activity of antibiotics decreases because of the resistance of pathogenic microorganism, being of crucial importance the search of new drugs. The purpose of this study is to evaluate the antimicrobial and cytotoxic effect of a biosurfactant extract obtained from a fermented maize kernel extract against bacteria and fungi using in vitro assays. Methodology & Theoretical Orientation: Biosurfactant extracts were obtained from a fermented kernel extract by liquid-liquid extraction with ethyl acetate followed by the removal of organic solvent by distillation. Antimicrobial assays were carried out using pathogenic strains including E. coli; Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Aspergillus brasiliensis; whereas cytotoxic assays were carried out using fibroblasts. Findings: The biosurfactant extract under evaluation showed an important antimicrobial activity against bacteria and fungi being able to kill them in vitro assays, without observing relevant cytotoxic effect on fibroblasts. Figure 1 shows the general structure of lipopeptides forming micelles and a pathogenic microorganism. Conclusion & Significance: Based on the antimicrobial spectra of the biosurfactant extract obtained from maize fermented kernel it could be speculated that biosurfactants of microbial origin, could be included in pharmaceutical formulations alone or in combination with other drugs as a new generation of active principles.

  • Drug Discovery and Development
Speaker
Biography:

Priyanka Karpe currently working as Assistant Professor in one of the esteemed Vishwakarma University (VU) in Pune, India, also previously having work experience as research scientist; dedicated for analytical method development and validation of Dry powder inhaler, Metered dose inhalers, Nebulizers and Nasal spray preparation also having an experience in various solid and liquid dosage forms; 8 years of experience in Pharmaceutical industry with GMP/GLP guidelines, Handling HPLC, separation laboratory techniques of GMP/GLP. Possess excellent communication, researching, analytical, document writing and technical skills along with the ability to coordinate and work with cross-functional teams/partners/clients.

Abstract:

Statement of the Problem: Acetylcysteine and Ambroxol belongs to the class of drugs called 'mucolytic agents', primarily used to prevent and treat symptoms of chronic obstructive pulmonary diseases (COPD), such as coughing, wheezing and shortness of breath. COPD is a group of lung diseases that mainly include emphysema, pneumonia and chronic bronchitis. These two mucolytic agents help in thinning and loosening phlegm in lungs, windpipe, and nose to provide relief from respiratory problems like coughing, wheezing, and shortness of breath. Ambroxol is also an expectorant promotes mucus clearance, facilitates expectoration and eases productive cough, allowing patients to breathe freely and deeply promotes the secretion of sputum by the air passages. Acetylcysteine serves as a prodrug to L-cysteine, a precursor to the biologic antioxidant glutathione; the oxidized glutathione and S-nitrosoglutathione bind to the glutamate recognition site of the NMDA and AMPA receptors and mucolytic activity takes place.  Findings: Precise RP-HPLC analytical method developed for the For the simultaneous estimation of Assay and Impurity profiling study determination of both assay and related substances in Ambroxol hydrochloride and Acetylcysteine tablet dosage form with gradient elution pattern having mobile phase A as buffer pH 3.0 and mobile phase B as an Acetonitrile at 1.0mL/min flow rate, using Inertsil ODS 3V column, 40°C column temperature and PDA detector with wavelength 230nm. The analytical method is validated as per ICH guidelines including its forced degradation studies. The method was found to be linear in the range of 0.2ppm to 2.5ppm with correlation coefficient 0.999. Accuracy performed at LOQ to 250% level and recovery was found to be in the range of 95% to 105%. Conclusion & Significance: The developed analytical method thus provides a safe, easy and reproducible solution for the stability studies and QC release testing for the estimation of assay and related substances.