5^th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 16-18, 2015 Crowne Plaza, Dubai, UAE

Biography:

Chemical Engineering degree. Involved in Clean Room technologies since 1980. At present he is in charge of the Integrated Projects Business Unit at Fedegari Group, dealing with the design and the supply of new solutions for the sterile drug manufacturing including GMP robotics. Scientific Technical Association activities: member of the board of the Italian association of contamination control ASCCA (www.ascca.net) since 1986, President of ASCCA 1998-2000, ISPE member since 2001. At present ASCCA vice president. Promoter and responsible of the training course on “General introduction on Clean Room technology, isolation concepts and critical parameters definition”. Trainer on pharmaceutical HVAC design at La Sapienza University (Roma) for students of chemical and pharmaceutical technology. Author of several papers on clean technologies and experienced giving training lectures to AIFA GMP Italian inspectors.

Abstract:

One of the most problematic issues of the aseptic manufacturing is the involvement of the personnel. Human being is generating every minute million of particles and some of them are biologically active and might generate a product contamination. Now the technology can help us in removing from the aseptic manufacturing equation the human being and the relevant impact in the sterility of the product. Stainless Steel GMP robotic arms have been introduced to handle fill finish operation within a gloveless isolator. The advantage of this solution, apart from sterility improvement, is the possibility to handle High Potent Active Pharmaceutical Ingredients (HPAPI) like cytotoxic drugs. The presentation will go through all the main features of this gloveless robotic solution.

Biography:

Husam Younes is a graduate of the Faculty of Pharmaceutical Sciences at the University of Alberta (UA) in Edmonton, Alberta, Canada. He received his BSc (Pharm) in 1992 followed by MSc (Pharmaceutical Technology) in 1995. He worked as a Technical Manager in the Pharmaceutical Industry in Palestine and Jordan then completed his PhD from UA in 2002. In August 2007, Younes moved to Qatar to start his new career as the Founding Chair of Pharmaceutical Sciences department in the new Pharmacy Program at Qatar University. He is currently an Associate Professor of Biopharmaceutics at the College of Pharmacy and the founder of the new Pharmaceutics and Polymeric Drug Delivery Research Laboratory. He previously worked in the pharmaceutical industry and also as a senior consultant to Newfoundland Health Department in Canada. His main research is in the areas of controlled drug release, biomaterials, tissue engineering and synthesis of novel biodegradable polymers designed for localized and targeted delivery of therapeutic proteins in cancer therapy. Younes supervised graduate students and postdoctoral fellows in his lab and acted as an editorial board member and a reviewer for many pharmaceutical and drug delivery journals.

Abstract:

Purpose: To formulate and evaluate oral dosage forms of Metformin hydrochloride (MH) having sustained-release properties that would also increase MH bioavailability and address the shortcomings in the currently marketed sustained release tablets.

Methods: MH micronized powder was dispersed in molten polymeric matrices composed of Gelucire® 50/13 and various proportions of high molecular weight hydrophilic polymers, hydrophobic oily semisolid excipients, and mucoadhesive polymeric materials. The MH loaded matrices were filled in hard gelatin capsules (HGC) each containing 500 mg MH and were subsequently characterized using Differential Scanning Calorimetry (DSC) and X-Ray Diff raction Analysis (XRD). The prepared HGC were subjected to content uniformity and in vitro dissolution testing according to the USP-35 compendial requirements. The dissolution data were compared to instant and sustained-release marketed tablets. Th e effect of incorporating various proportions of the semisolid excipients on MH dissolution release rate, were also investigated.

Results: MH content of the prepared HGC ranged between 96 to 103%. All the prepared semisolid fi lled HGC resulted in extended release profiles of MH that lasted between 5 to 11 hours and demonstrated a release pattern which typically follows the release from mixes of triglycerides with polyethylene glycol esters of fatty acids. Th e incorporation of muco-adhesive excipients like Carbomer to the Gelucire® 50/13-MH semisolid matrices extended the release of MH from 5 hours initially to 9 hours as a result of the formation of a gel layer around the matrix. However, the incorporation of diff erent hydrophilic excipients like PEG35000 and Gelucire® 44/14 along with the muco-adhesive excipients sustained the release of MH up to 11 hours. XRD analysis of the MH prepared matrices demonstrated minor changes in the crystalline nature of MH. Depending on the loading ratios and the nature of the semisolid matrices used, DSC analysis revealed the changes in MH crystallinity to be from 100 to 23 %.

Conclusion: HGC formulated using semisolid matrices showed promising results in extending the release of MH. However, bioavailability studies to test the ability of such Gelucire based HGC of MH to improve its bioavailability and in vivo residence times are future plans.

Acknowledgements: This work was made possible by a NPRP award [NPRP 09-795-3-215] to HM Younes from the Qatar National Research Fund (a member of The Qatar Foundation). The statements made herein are solely the responsibility of the authors.

Biography:

NaglaaG.Ahmed is a Associate Professor, Pharmaceutical Chemistry and Natural products Department, Dubai Pharmacy College, Dubai, UAE. She graduated from Faculty of Pharmacy, Cairo University, Egypt and received the PhD from the same college. She is a member in American society of Pharmacognosyand in Italo-Latin American Society of Ethnomedicine and as editorial board member in Natural Products Chemistry and research. Also she is a reviewer for many international Journals concerning chemistry and biological activity of medicinal plants. She published at least 30 scientific papers also contribute in publication of scientific book and her interest field is in bioactivity of medicinal plants.

Abstract:

Introduction: Liver diseases are considered as one of the serious health problems, as it is an important organ for the detoxification and deposition of endogenous and exogenous substances. A number of pharmacological and chemical agents act as hepatotoxins and produce a variety of liver ailments. Steroids, vaccines and antiviral drugs which have been employed as a therapy for liver diseases, have potential adverse effects especially when administered for long terms.Traditional healing practices are nowwidespreadamongst about 80% of the developed countries population and often termed alternative or complementary medicine. Aim:In the absence of reliable liver-protective drugs in modern medicine, hepatoprotective drugs from plant sources seem to have attractive alternatives.The aim of thisscientific lectureis designed to focus in the medicinal plants as well as the other alternative medicines which can be used as hepatoprotective and antihepatotoxic agent. Methodology: MedicinalPlants that are found in the Arabic Gulf, India and United State of America with scientific researches will be discussed in this lecture. The active constituents, mechanism of actions, safety, side effects and the contraindication of each plant will bediscussed as well. Other alternative medicines like aromatherapy, acupuncture therapy, breathing therapy and relaxation therapy will be deliberated. Those are found to be effective therapies in the protection of liver from many diseases.

Biography:

Abstract:

Osteoarthritis (OA) is among the most prevalent chronic human health disorders and the most common form of arthritis. It is among the leading cause of disability worldwide and with increasing life expectancy; OA is a major socioeconomic and clinical concern.OA is characterized by cartilage deterioration/damage, infl ammation, synovial fi brosis, subchondral bone remodelling and osteophyte formation. Aetiology and pathogenesisunderlying OA is poorly understood. Several preclinical animal models (large and small animal models) have been used to understand the mechanisms associated with the pathophysiology of OA disease. Further, several models serve as an essential tool to determine drug bio-distribution, activity, safety as well as the therapeutic eff ects at pre-clinical phase. In my talk, I will shed light on the usefulness and limitations of using small animal models of osteoarthritis in understanding (a) mechanisms of disease as well as in (b) drug delivery, biodistribution, activity, safety and therapeutic eff ects.

Biography:

Rob Schultheis is a President for ZebraSci/Mantis Vision Systems, USA. He completed his Master of Science (MS) and BS, Mechanical Engineering from Drexel University.

Abstract:

Autoinjector device performance is greatly impacted by primary container quality. In order to ensure a robust design, a thorough forensic analysis of all variables need to be understood as they eff ect performance. From this understanding specifi cations can be derived in order to ensure a successful injection every time. Th is presentation outlines how to practically observe variation in primary packaging as it relates to device performance and then links this gained knowledge to how to derive a robust specifi cation.

Biography:

B. B. Barik has completed his PhD in 1993 from Jadavpur University, Kolkata, India. He is the Professor in the department of Pharmaceutics, College of Pharmacy, Jazan University, Kingdom of Saudi Arabia. Earlier he worked as professor and head in the Univ Dept of Pharm Sci, Utkal University, Bhubaneswar, India and College of Pharmaceutical Sci, Berhampur, Odisha. He has published more than 50 papers in reputed journals and presented more than 100 papers in national and international conferences. He is serving as reviewer and editorial board member of reputed journals.

Abstract:

Antibiotic resistance is one of the major health problems worldwide. Resistance to penicillin is well recognized in Staphylococcus aureus and Staphylococcus epidermidis. During last decade various resistance mechanisms such as decreased uptake, increased effl ux of drug from bacterial cell, formation of biofi lms to avoid contact with antibiotics have been identifi ed that lead to failure in the treatment. Th e concept of drug delivery system is rapidly moving towards the development of biodegradable polymeric nanoparticles. For past two decades many researchers have been developing nanoparticle drug delivery especially delivering of anticancer drugs and vaccines. Th e main advantage of this system is to deliver drug moiety at the site of cell that can improve pharmacokinetic and pharmacodynamic profi les of the drug. Th us the nanoparticles improve solubility, stability and bioavailability of various drugs. However, it is limited by toxic profi le. Th erefore, nanoparticle drug delivery system is highly challengeable for researchers to overcome toxicity. Th e application of nanoparticle in the fi eld of Medicine and Pharmaceuticals will be exposed more and more in near future. In our study, the antibacterial effi cacy of penicillin loaded chitosan nanoparticles was evaluated against selected bacterial strains namely Staphylococcus aureus, Streptococcus pyogenes, Bacillus subtilis, Escherichia coli and Klebsiella planticola of clinical origin. Th e study suggested that penicillin nanoparticles showed better antibiotic delivery system than conventional penicillin. However, the study is still under process in order to overcome lacunae that we experienced in our earlier studies.

Biography:

Nawal Khalafallah Current research interests include improving drug performance using lipid vesicles as carriers. Industry-related research interests include looking at the effect of source of excipients on excipient characteristics, and on product performance. Participated in developing a postgraduate two year PharmD program for hospital pharmacists

Abstract:

Several published articles have tackled the issue of improving vancomycin performance. Th e performance areas targeted in these studies included broadening antibacterial spectrum to include Gram-negative organisms, enhancing antibacterial activity against drug resistant Staphylococcus aureus and enhancing the antibiofi lm activity. One of the active research areas in the Department of Pharmaceutics has been lipid vesicles including liposomes and niosomes among other types of modifi ed liposomes such as propylene glycol liposomes with the aim of using these vesicles as vancomycin carriers to improve antibiofi lm activity including inhibition and eradication of biofi lms forming on abiotic sufaces such as catheters. Th is presentation focuses on challenges encountered, and on lessons learnt, while conducting research in this area. Some of the challenges are related to vancomycin itself and some arise from the methodology used. Th e presentation also touches on speculation of how to move such systems from bench to bedside.

Biography:

Ruchi Chawla is an Assistant Professor at Department of Pharmaceutics, Indian Institute of Technology (Banaras Hindu University), Varanasi. She has 6 years of teaching and research experience. Her areas of research are anti-microbial chemotherapy, nanotechnology and herbal drug delivery. She has a strong academic background and has published papers in reputed journals. She is also serving as an Editorial Board Member.

Abstract:

Solid lipid nanoparticles of curcumin (C-SLNs) were prepared using stearic acid as lipid carrier by nano precipitation technique and characterized for their physio-chemical properties. SLNs were incorporated in hydro gels prepared from Carbopol®934 and the eff ect of method of incorporation of SLNs on the hydrogel properties was studied by Texture Analyzer. For the purpose of study, three types of hydro gels were prepared, i) Blank hydro gels B1, B2 and B3 containing respectively 0.5, 1.0 and 2.0 % w/v carpobol; ii) In-situ hydro gels Y1, Y2 and Y3 by adding carbopol (0.5, 1.0 and 2.0 % w/v) to fi xed volume of C-SLNs suspension and; iii) Enriched hydro gels by mixing C-SLNs and blank carbopol (1% w/v) hydrogel in the ratios 1:1 (D1) and 1:2 (D2). C-SLNs exhibited a mean particle size of 527.6 nm, poly dispersity of 0.383 and 82.73% entrapment efficiency. In-situ hydro gels exhibited a concentration (carbopol) dependent increase in fi rmness, consistency, cohesiveness and viscosity, however, presence of C-SLNs signifi cantly decreased (p<0.05) these values in comparison to blank hydro gels. Similar observations were made in enriched hydro gels. Also, a signifi cant difference (p<0.05) in hydrogel properties was observed between in-situ and enriched hydro gels. It indicates that SLNs have an eff ect on the swelling properties of Carbopol. Occlusive properties of in-situ hydrogels were better than enriched and blank hydro gels. In-situ hydro gels also exhibited uniform and extended release of curcumin, along with higher permeation characteristics. Better formulation characteristics of in-situ hydro gels might be because of homogenous deposition and gelling of carbopol around curcumin nanoparticles.

Biography:

He was born on the 2nd of March in 1986 in Carrara (MS), Tuscany (Italy) and is currently a MD, a MSc, a PhD and a resident in Public Health. He got his MD (medical degree) on the 15th of July in 2011 with a final mark of 110/110 cum laude with a thesis on Personalized Nanomedicine ("Nanomolecular aspects of medicine, at the cutting-edge of the nanobiosciences in the field of health-care") and the joint Italo-Russian MSc (Master of Science) in nanobiotechnologies at Lomonosov Moscow State University (27th April 2012). He got his PhD in nanochemistry and nanobiotechnology at Marburg University, Germany with a final mark of “very good” and is currently a resident in Public Health at University of Genoa, Italy, 3rd year. He is author and/or co-author of several publications.

Abstract:

Ramadan fasting represents the fourth of the five pillars of the Islam creed ('aqidah). Even though patients are exempted from observing this religious duty, they may be eager to share this particular moment of the year with their family and peers, by attending the special prayers, social gatherings and other ceremonies. However, there are no guidelines or standardized protocols that can help physicians to properly address the issues and concerns of patients willing to fast in Ramadan and correctly advising them. Despite the extensive body of studies conducted on Ramadan fasting, so far only clinical parameters and analytical chemistry have been used and assessed. There is a dearth of systems biology- and omics-based studies, which investigate biological events from a global perspective, not focusing on single candidate clinical biomarkers but taking into account the entire overall perturbations, by means of high-throughput technologies. Systems biology and omics sciences could assess the metabolic effects of Ramadan fasting, confirming well-known and expected metabolic perturbations, and adding knowledge on both the short-term and long-term effects of Ramadan fasting. Systems biology and omics sciences could undoubtedly constitute a fundamental step further and a crucial advancement in the field of the relationship between religion and health. It can be anticipated that these highly advanced specialties provide a unique, unprecedented opportunity for studying the physiology and physiopathology of fasting, giving personalized counseling and advice to patients willing to fast during Ramadan.

Biography:

Maha Aboul Ela, graduate of Faculty of Pharmacy, University of Alexandria, Egypt. Ph D in Pharmaceutical Sciences (Pharmacognosy) 1991, University of Alexandria-Egypt and Technical University of Berlin-Germany. She had done her Postdoctoral fellowship, from School of Pharmacy, University of London, UK. She is Member of the American Society of Pharmacognosy. She is also Member of the editorial board of many international scientifi c journals. Currently, she is head of department of Pharmaceutical Sciences, Faculty of Pharmacy, Beirut Arab University, Lebanon.She is Expert in QA in Higher Education. Research interest: Phytochemistry, Phytotherapy, discovering new drugs from natural sources and participation in drug development through applying different pharmaceutical approaches, more than 55 publications in the fi eld of phytochemistry, medicinal plants and phytotherapy.

Abstract:

The Middle East region is a major source of phytotherapeutic natural products. Different pharmacological studies on the Middle East medicinal plants revealed their signifi cant importance as new sources of drugs. Focusing on endocrinal and neurological diseases, a number of Middle East plants had shown signifi cant potentials towards these diseases. Salvia libanotica fruticosa, Centaurea horrida; Hordeum spontaneum and Rheum ribes are herbal plants indigenous to ME region and had shown notable eff ects on Diabetes mellitus and one of its related complication; the painful diabetic neuropathy. Diabetic neuropathy is the leading cause of neuropathy in the world today. Diabetic neuropathy has a few approved therapies for the management of pain with limited effi cacy and side eff ects. With the aim to explore and develop new phytotherapeutic agents, we investigated the antidiabetic and antihyperalgesic properties of some Middle East natural products in alloxaninduced diabetic mice. Th e results of our experiments indicated that, these plants exhibited a remarkable effect against diabetic neuropathy. More experiments should be done to complete these plants’ profi le before their dispensing in suitable dosage forms to facilitate their delivery to the targeted sites.

Biography:

Hassane Sadou Yaye completed his Pharma D and, he is head of the laboratory of quality control of pharmaceuticals in the department of Pharmacy (Pitie- Salpêtriere hospital - Paris); and PhD student (University Paris Sud). His research focuses on APIs intrinsic stability studies which include the structure elucidation and the main routes of their degradation.

Abstract:

Ticagrelor is a direct-acting and reversible P2Y12-adenosine diphosphate (ADP) receptor blocker used as antiplatelet drug. Th e drug was subjected to force degradation studies under several stress media. Th e degradation products generated have been detected and identifi ed by high-pressure liquid chromatography multistage mass spectrometry (LC-MSn) along with high-resolution mass spectrometry. C18 XTerra MS column combined with a linear gradient mobile phase composed of a mixture of 10 mM acetate ammonium/ acetonitrile was shown suitable for drug and impurity determinations and validated as a stability indicating method. Structural elucidation of the degradation products relied on MSn studies and accurate mass measurements giving access to elemental compositions. Up to nine degradation products resulting from oxidation/ autooxidation, S-dealkylation and N-dealkylation have been identifi ed, covering a range of possible degradation pathways for derivatives with such functional groups. Kinetics was also studied in order to assess the molecule’s shelf-life and to identify the most important degradation factors. Eventually, an in silico toxicological study was undertaken starting from the structure of the degradation products in order to know any potential risk resulting from drug degradation.

Biography:

Abstract:

The performance of the novel chitin metal silicate (CMS) co-precipitates as a single multifunctional excipient in tablet formulation using direct compression and wet granulation methods is evaluated. Th e neutral, acidic, and basic drugs Spironolactone (SPL), ibuprofen (IBU) and metronidazole (MET), respectively, were used as model drugs. Commercial Aldactone®, Fleximex® and Dumazole® tablets containing SPL, IBU and MET, respectively, and tablets made using Avicel® 200, were used in the study for comparison purposes. Tablets of acceptable crushing strength (>40 N) were obtained using CMS. Th e friability values for all tablets were well below the maximum 1% USP tolerance limit. CMS produced superdisintegrating tablets (disintegration time < 1 min) with the three model drugs. Regarding the dissolution rate, the sequence was as follow: CMS > Fleximex® > Avicel® 200, CMS > Avicel® 200 > Dumazole® and Aldactone® > Avicel® 200 > CMS for IBU, MET and SPL, respectively. Compressional properties of formulations were analyzed using density measurements and the compression Kawakita equation as assessment parameters. On the basis of DSC results, CMS co precipitates were found to be compatible with the tested drugs. Conclusively, the CMS co-precipitates have the potential to be used as fi ller, binder, and superdisintegrant, all-in-one, in the design of tablets by the direct compression as well as wet granulation methods.

Biography:

Hijazi Abu Ali is an associate Prof. in the field of medicinal and bioinorganic chemistry. He is the chairperson of Chemistry Department at Birzeit University, Palestine. He has published more than 30 publications (papers, reviews, books) in reputed journals and agencies. In addition he has been serving as a reviewer for several journals.

Abstract:

Starting from the precursor [zinc carboxylate complex], where (carboxylate = valproate, naproxenate, ibuprofenate, indomethacinate, diclofenate and sulindaco) and nitrogen based ligands, different Zinc(II) complexes with the general formula [Znm(carboxylate)n(L)x] where; (L = 2,9-dimethyl-1,10-phenanthroline, quinoline, 2-aminopyridine, 2-amino-6-picoline, 2-aminomethyl pyridine, 1,10-phenanthroline, imidazole, 2,2’-bipyridine and 4,4’-bipyridine) were synthesized and characterized using IR, 1H NMR, 13C{1H} NMR and UV-Vis spectrometry. The crystal structures of some complexes were determined using single-crystal X-ray diffraction. The complexes were also evaluated for their anti-bacterial activity using in-vitro agar diffusion method against three Gram-positive (Micrococcus luteus, Staphylococcus aureus, and Bacillus subtilis) and three Gram-negative (Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis) species. Most complexes showed considerable activity against all tested microorganisms and the effect of complexation on the anti-bacterial activity of the parent ligands was also investigated. The anti-bacterial activity of some complexes against Gram-negative and Gram-positive bacteria was enhanced upon complexation, other complexes showed weak inhibition activity against the tested species. On the other hand some complexes didn’t show any activity at all. Two methods were used for testing the inhibition of ferriprotoporphyrinIX bio-mineralization: a semi-quantitative micro-assay and a previously self-developed quantitative in-vitro method. Both were used to study the efficiency of these complexes in inhibiting the formation of the Malaria pigment which considered being the target of many known anti-malarial drugs such as Chloroquine and Amodiaquine. Results showed that the efficiency of some complexes preventing the formation of β-Hematin was 80 % or higher. The efficiency of Amodiaquine as a standard drug was reported to give 91 %.

Biography:

Dr. Hsing-Pang Hsieh has completed his PhD in 1993 from SUNY at Stony Brook, USA and postdoctoral studies from Boston College, USA and Academia Sinica, Taiwan. He is Investigator of Institute of Biotechnology and Pharmaceutical Research, National Health Research, Institutes. He has published more than 100 SCI papers and obtained 43 patents granted and invented anticancer drug, DBPR104, which is currently undergoing clinical trial in Taiwan.

Abstract:

Aurora kinases A, B, and C, members of sereine/threonine kinase, are key mitotic regulators involved in maintaining the genomic integrity of daughter cells. Because over-expression of Aurora A and Aurora B is frequently associated with tumorigenesis, these molecules have been targeted for cancer therapy. Based on the structural analysis of the known Aurora kinase inhibitors and pharmacophore screening from in-house HTS compound library, we developed BPR1K0871 as the 4th generation of lead compound. BPR1K0871 was identified as a novel multiple target kinase inhibitor that possessed an impressive inhibition activity in Aurora-A kinase (IC50 = 22 nM), FLT-3 kinase (IC50 = 19 nM) and other 17 oncogenic related enzymatic assays in nano molar range. It not only showed potent cell growth inhibitory activity against a panel of various cancer cell lines, but also exhibited highly potent in-vivo efficacy in MOLM-13, MV4;11, MIA-Paca2, AsPC-1 and Hep3B subcutaneously xenografted nude mice models by iv. administration. To further improve the pharmacokinetic properties of BPR1K0871 by utilizing “drug-Like” properties optimization, prodrug, and oral formulation approaches, we identified several potent compounds that display promising oral bioavailability. In particular, BPR1K1201 not only possesses remarkable in vitro potency but also significantly improved pharmacokinetic profiles to achieve high oral bioavailability (~46%). This breakthrough finding has fueled our interest and focuses on identifying orally active anticancer drug.

Biography:

Abstract:

Solid and semi-solid dosage forms are the most widely marketed and administered drugs nowadays. Almost 70% of the administered drugs are in solid states. It is preferred by the pharmaceutical companies due to its high safety, low cost and marketing issues. Pre-formulation is a stage of development during which the physicochemical properties of drug substance are characterized. Before the formulation of a drug substance into a dosage form, it is essential that to be chemically and physically characterized. Pre- formulation begins with calculation/prediction ‘in silico’ of many of the important physicochemical characteristics of the API. Literature search of similar type of compounds is the second step of pre-formulation process. Pre-formulation infl uences on selection of the drug candidate itself, selection of formulation components, API & drug product manufacturing processes, determination of the most appropriate container closure system, development of analytical methods, assignment of API retest periods, the synthetic route of the API and toxicological strategy. Th e most important function of pre-formulation stage is solid state characterization which determines the next step in the formulation work of the studied API. Physical properties of the studied API infl uence on its physical and chemical stability. It infl uences on the rout of administration, delivery system and the drug activity. Moreover, Chemical stability of the drug is aff ected by the physical properties. Crystal morphology, polymorphism, amorphous forms and hygroscopicity are usually studied. In addition, solubility, salt form, melting point, dissolution of the API are also studied. Certain properties are studied in pre-formulation stage of the solid dosage forms. Th ese properties relate mainly to the ability of the powder to fl ow in the compressing machine and subsequently its compressibility. Th ey infl uence on the dissolution rate of the API, stability, bioavlaibility, degradation rate and purity. Th e studied properties include particle size, its distribution, its surface area and porosity. It includes also true density, fl owability, API color, electrostaticity, caking and polymorphism.