Workshop on HPLC by Joe Ocando

 

To raise new questions, new possibilities, to regard old problems from a new angle, requires creative imagination and marks real advance in science’ – Albert Einstein. 

With the same pace and eagerness to learn AAPS student chapter hosted another workshop and this time for learning high performance liquid chromatography (HPLC) and it’s instrumental training. For second consequent time  we were fortunate to have Joe with us for the workshop held on on 23rd Oct, 2015. The highly trained and very professional Joe introduced HPLC with the theoretical concept of chromatography. With a simple yet informative video he described its operation. The lecture proceeded discussing different challenges and their ‘quick fix solutions’. Thereafter qualified candidates were selected for instrumental training held on 30th Oct 2015.They had hands on experience with the HPLC under Joe Ocando’s supervision.

Answers from the debrief

How does it work? The components involve a reservoir that holds the solvent, a high-pressure pump, an injector/sample manager and the HPLC column. A detector is needed to see the separated compound bands as they elute from the HPLC column. The mobile phase exits the detector and can be sent to waste, or collected, as desired. When the mobile phase contains a separated compound band, HPLC provides the ability to collect this fraction of the eluate containing that purified compound for further study.He emphasized how important it is to understand a chromatogram and its extrapolation for the compounds desired in separation.

How do I choose? The importance of detector was explained along with how a choice is made among many different types of detectors, depending upon the characteristics and concentrations of the compounds that need to be separated and analyzed. In a conventional UV-Vis detector, manual or a motor governed mechanical movement is required to select a specific wavelength. But a photodiode array UV-Vis  acquires data at each wavelength by electrical scanning.The wavelength is therefore reproducible in a PDA instrument and is much better than the conventional mechanical scanning UV-Vis spectrophotometer.

What is important before I start HPLC?

  • Precautions like purging and stabilizing column before method run
  • System suitability parameters and their weighing during method development and validation.
  • Sample preparation
  • Column maintenance and efficiency considerations

Analytical Competency?

Yes we are competent in carrying out analytical research. Joe was generous to have helped one of our graduate students by recommending the software version required for specific system from the Waters company. His advice had impacted the student’s research work significantly. He’s in depth knowledge of Analytical Chemistry and commercialized approach for selecting an equipment specific for the use always comes handy for our fellow researchers.

 

Workshop on NMR by Joe Ocando

On 20th Nov, 2015 AAPS student chapter hosted a workshop for learning NMR spectroscopy and instrumental training. NMR is an analytical instrument used in various fields of research for identification and characterization of compounds or drugs.

Joe is an expert in many analytical instruments like HPLC, FTIR, NMR and GC-MS . He has a BA/MS degree from the Department of Chemistry at New York University and specializes in analytical chemistry. Joe has served at Pfizer for 8 years in the Technical Services and Quality Operations groups before coming to St. John’s. It was our immense pleasure to have Joe to share his expertise with us.

We started the workshop with the introduction to this analyt instrument- NMR (Nuclear Magnetic Resonance). He discussed the theory and practical aspects of using this instrument. He specified intricate details to enable handling of various components of NMR in order to avoid huge losses (in terms of repair of course!). Speaking of which, it was great to have Dr. Graham who gave his valuable inputs regarding the working and use of NMR.

Joe explained us the importance of taking certain precautions like making sure that the NMR room is kept under cold conditions etc. It was fun to understand more about the technique by watching videos which Joe had compiled to familiarize us with the software. The enthusiasm of students was appreciable, we found them asking questions and getting there doubts cleared from Joe. Towards the end we had a short quiz to check how well were the theoretical and practical aspects received.

On Jan 26th, 2016, the second day of the workshop the agenda was to provide hands on training on the instrument. Selected students were explained the operation of NMR instrument (Bruker) in a stepwise manner. Important measures were considered like mobile phones or any devices possibly with magnetic features must be kept away from NMR. This is because the NMR has strong magnetic field which can deactivate or destroy such devices.  Moving on, he explained with the example of a reference how sample is prepared and why do we use deuterated solvents for proton NMR. It is always a challenge to just read and actually use a piece of instrument, isn’t it? We could experience this exactly, since it took a lot of time for us to do shimming (one of the steps to fine tune the probe)! Later on, he explained the analytical part using the software (Topspin) and how to interpret the data.

Overall, it was a great opportunity to learn about NMR. We are grateful to Joe for his time and efforts in making this event a success !

Guest Lecture Series Fall 2015

With the same informative and collaborative approach AAPS student chapter was able to conduct another guest lecture this semester for the third time. We were pleased to have Dr Inayet as the speaker for the event held on Novemeber 18th 2015. Dr Inayat was sharing her views on “Lipid Based Systems for Solubility & Bioavailability Enhancement”. Presently serving as the Technical Manager at the Gattefossѐ, she is involved in providing scientific, regulatory and quality support to sales and marketing teams across the firm’s American and Mexican market. Previously she has served as a Scientist at various Pharmaceutical Industries including IPM, Sandoz and Kos. She is experienced in formulation development for orals, topical and inhalations. She is a BSc graduate from Ankara Univeristy and a PhD graduate from Rhode Island with the dissertation on lipid based delivery systems in oral bioavaibility enhancement.

IMG_20151113_133916_1

What she had to say?

She introduced Gattefossѐ as being the firm having headquarters in Lyon and France and having more than 60 subsidaries. It specializes in Personal care and Pharmaceuticals. Under Personal care it handles Excipients and APIs whereas at Pharmaceutical it does oleochemistry and Excipients + Formulation Technologies. The firm has created more than 25 new NF/EP monographs since 2004. It has pioneered in SNEDDS SMEDDS and SNEDDS developments along with melt techniques for taste masking or sustained delivery. In the next part of the presentation she briefed us on how the chemistry and the physical properties were evaluated in making the excipients. Amongst the applications of these lipid excipients as vehicles for oral delivery she had emphasized them as lubricants, granulation aides, neutral carriers for coating, taste masking , matrices for sustained / modified release, multi-particulates systems, solubilizers, bioavailability enhancers and self micro-emulsifying lipid formulations. She also shared her insights on lipid solubility for various drugs and their miscibility while formulating a lipid based system. She reiterated the approaches to be used during formulation and the aspect of carrying out in-vitro characterization involving lipolysis. The talk was concluded with various aspects of presystemic metabolism and lymphatic transport.

Take home message.

At the end of the talk students had a glimpse of how the lipid excipients can be used in research of lipid based formulations and the importance of the parameters like solubility, miscibility, in vitro characterization and mechanism of bioavailability enhancement for these excipients.

We found Dr Inayet highly passionate, cordial and motivating in her interaction with the students. Her talk was thought provoking and a perfect blend of science and learning.

image1
Token of appreciation from the Chair

Guest Lecture Series Fall 2015

Celebrating the success of our foremost talk from the guest lecture series, we were inspired to host the second event on 13th November 2015. The Speaker for our talk was ‘Erika Bartholomew’ an elite scientist from Merck. She is working with Merck for the pre-formulation group since June, 2013. She supports early discovery efforts and studies transitioning new chemical entities into early development.  On the day of the event she was with us to address the course of a compound’s “discovery phase”, how the animal studies are routinely performed to evaluate oral absorption and pharmacokinetic (PK) parameters. She also briefed us on how ideal formulation is designed to enable the highest exposure for in vivo studies from pre-clinical studies through large toxicology studies to support Phase I (First in Human) clinical trials.

erika

What she had to say?

Her talk entitled ‘From Molecules to Medicines: The Role of Discovery Pharmaceutical Sciences in Drug Development’ began with an opening slide on highlighting where Discovery Pharmaceutical sciences operates in the drug discovery process. Different aspects of Physical pharmacy including crystallinity, hygroscopicity and particle size determinants were touched upon. From Pharmacokinetics point of view, emphasis was laid on how the change in formulation can affect the rate and extent of absorption. Under conventional and enabled formulations, she described how are nanosuspension formulated on large scale. Maintaining a safety margin of 10 x they are used to successfully dose through all the major routes except oral depending on the needs of the program. With an appropriate data of PK study for a compound she illustrated why a spray dried product was more preferable over others. A case study exemplified on how food can affect the bioavability of some drugs. Various In vitro and vivo tools were described to support the idea of risk associated with food effects.

To summarize the talk she gave us few important pointers. These include considering physiochemical properties of API and technologies which have evolved to improve the safety and efficacy.

IMG_2358

Take home message.

Spreading slight humor she ended the talk with a perfect quote from a scientist comment, ‘We don’t get it, we design one pill for all maladies and marketing tells us there’s a design flaw!’ Unbeatable and widely accepted truth of a scientist and marketing minds struggling to align was righteously addressed.

 

 

 

Guest Lecture Series Fall 2015

Welcome to the Fall Semester! AAPS student chapter is back with all new exciting networking events. The first speaker for our Guest speaker series was Dr. Andy Vick who is serving as the Vice President of Analytical Services at WIL Research. He was here on September 17th 2015, to share his insights on ‘Emerging trends in pharmaceuticals and bio pharmaceuticals’.

Andy started his journey as the Principal scientist at Biogen and Elililly. He then served as the Director and Vice President at Millipore and Seventh Wave Laboratories. Currently being the Vice President at WIL Research he is involved in various tasks involving scientific, operational, and financial performance of Analytical Chemistry, Formulation Science, Bioanalytical Chemistry, Immunoassay, and ADME/DMPK. He is also contributing towards the progress of AAPS and International Federation of Pharmaceutical Scientists (FIP) by being the part of team of  Directors.

Possessing a versatile persona, Andy had shared his views which reflected a combination of his sophisticated scientific knowledge, his keen business insights, and great soft people skills.

What he had to say..?

The agenda of his talk was to focus on the changing scenario of the Pharmaceutical Industry and how we as scientists can benefit by preparing ourselves for the future. Research is no longer about Pharmaceutical company or R&Ds but it also involves starts ups, CROs and academic labs. Forecasters predict that the market for prescription drug sales will grow by 5.1% per year to reach 1T$ by 2020.  2015 seems a promising year with a predicted growth of 5.4%. Talking about the trends in Pharmaceutical market, most of the profits from the industry will come from oncology, biologic drugs and most probably therapeutic vaccines. He reiterated the fact of sustainable trend with a prompt example of Roche Pharma which will continue to be the largest player in the oncology market with >25B in sales; accounting for over 1/3 of the market.  They are expected to top the charts entirely through 2020. Speaking of the market trends, he emphasized on the observing that the US sales for the NME’s has been on the rise in recent years, 2013 being the bumper year.

Since 2013 on an average 30-40 NME’s are being approved every year.He drew our attention towards the fact that we should not only acknowledge the profit of big companies but also that of relatively smaller companies. For instance, Gilead sciences showed more than double increase in profit in last 1-2 years.This leaves the emerging Pharma Industry highly competitive and profitable as global demand for new and improved medicines increases. Hence job opportunities will remain ever-growing and intense.

More than just technical skills he stated the importance of having an attitude full of compassion, empathy and cordiality. Leadership, teamwork and networking are the necessary attributes, a good scientist should always possess. Speaking of performing well at a job interview he quoted that ‘You have only one chance to make the first impression’. The Employer’s goal is to determine in that limited time if we are capable of performing well for the aspiring position. For that he will look for a candidature of high competence, great enthusiasm with a positive mindset and personality.

Take home message.

The opportunities in Pharmaceutical field will always rise with time, but considering the above viewpoints of market trends and employ ability we the scientists will have a better edge over others.

Token of appreciation from Dr Lin
Token of appreciation from Dr Lin

Guest Speaker Presentation on April 8th, 2015

SJUAAPS participates in the Pharmacy Career Day!

SJUAAPS was represented by the committee Webmaster Ms. Shruthi Gobbooru, in the Pharmacy Career Day, held in the D’ Angelo Center, on Thursday, March 12th, 2015.

DSC_0148

Many reputed hospitals, Pharmacies and Governmental Organizations which recruit the Pharmacy students in Clinical and Hospital settings were present at the Career Day. Ms. Gobbooru interacted with many enthusiastic undergraduate Pharmacy students who wanted to know about the scope of Pharmacy students in an Industrial setting. She gave them insights about the work SJUAAPS does for students of the COPHS here at St. John’s University, and how undergraduate students can benefit from attending various workshops & guest lectures organized by SJUAAPS. She also spoke to them about the advantages of networking in the field of Pharmaceuticals. Many students also inquired her about how to become a part of AAPS and also expressed interest & signed up to become active members in the team of SJUAAPS.

Tidbits from our coffee hour with Dr. Barile

Hello everyone,

We hope that everybody had a great weekend, refreshed yourselves and are rejuvenated for the week ahead. The last week on Wednesday March 11 2015, enthusiastic undergraduate and graduate students had a very interesting get together with Dr. Frank Barile, the Chair of Pharmaceutical Sciences from our College of Pharmacy and Health Sciences, in the Sciarra room. Our learned professor from Industrial Pharmacy, Dr. Abu Serajuddin, also participated in the coffee hour. Dr. Barile and Dr. Serajuddin answered many questions and entertained ideas & suggestions from the students for more than an hour. Dr. Sabesan Yoganathan from our Medicinal Chemistry department and Dr. Simerdeep Singh Gupta, our Postdoctoral Fellow from Industrial Pharmacy department also gave their valuable insights during the meeting.

DSC_0135 DSC_0136

“Is there a chance for our graduate students from the college of Pharmacy, to take part in Industrial internships?”

“Will it be possible to setup a graduate student lounge in favor of the graduate students here from the COPHS?”

“Will it be a feasible idea to set up a common instrument room, accommodating expensive instruments, for the ease of research, and for the use by all graduate students alike?”

“What is the best way to join a research lab in the Pharmaceutical Sciences and how to choose a mentor?”

“What is the ideal timeline to be followed by the Doctoral students, starting from Day 1, which ensures a successful completion of their doctoral education within a span of 4-5 years?”

These are some of the questions posed by certain students and Dr. Barile & Dr. Serajuddin answered them in the best possible way. The discussion actually shed light on some of the administration-related topics which are also to be taken care of to ensure the smooth running of an educational institution and a successful research facility.

DSC_0134

Refreshments which were organized by our SJU-AAPS Vice-Chair Ms. Sayma Monir and our Treasurer Ms. Sowmya Gabbula, lifted up the tired-minds from the hectic work of the weekday. Though our students & staff had many other interesting topics for discussion, due to time constraints, the coffee hour was ended on a cheery note.

DSC_0143

In the end, Mr. Pulkit Khatri, Ex-Chair for SJU-AAPS (2013-2014) presented an appreciation certificate to Dr. Barile.

Dr. Frank Barile was positively delighted to find out about the involvement and dedication of SJUAAPS towards the betterment of professional & extracurricular grounds of the graduate student community of the COPHS.

Equipment Workshop Today!

Dear all,

Welcome to Spring 2015!

AAPS Student Chapter is pleased to invite you to an exciting opportunity to learn and get basic training in our equipment workshop on:

 “Hot Melt Extrusion” by

 Simerdeep Singh Gupta, Ph.D.

Post-Doctoral Fellow, St. John’s University

February 11, 2014 (Wednesday) @ 4-5 PM (B2, St. Albert’s Hall)

  *Refreshments served afterwards!

Abstract: The prospect for the development of solid dispersion has greatly improved during the past decade due to the introduction of hot melt extrusion (HME) in the pharmaceutical field. HME has many advantages over other solvent-based technologies used for preparation of solid dispersions. It is a continuous, less time-consuming process that can be scaled up relatively easily. It is also less prone to batch-to-batch variability than other processes. Also, being solvent-free, it poses minimal environmental hazards. However, there are still many challenges in the development of new drug products by melt extrusion. Being a relatively new technology in the pharmaceutical field, the formulation and processing parameters of HME are not fully understood. In most of the published reports, it is not defined how the appropriate polymers, drug-polymer blends and the processing temperatures are selected. A good understanding of the material properties, such as the glass transition temperature (Tg) and the melt viscosity of polymers as well as drug-polymer blends and the drug-polymer miscibility is needed before the development of processing conditions for any new products. The drug-polymer mixtures should also be extrudable at as low a temperature as possible to minimize potential of degradation of drug, polymer or both.

 About the Speaker: Simerdeep Singh Gupta, Ph.D. is currently a post-doctoral research fellow at St. John’s University, specializing in factors affecting miscibility and extrusion of solid dispersions of various drug-polymer combinations by hot melt extrusion technique. He received his Ph.D.’14 and M.S.’10 in Industrial Pharmacy at St. John’s University (Queens Campus, NY). His doctoral dissertation covered the research area of rheology aspects of Hot Melt Extrusion for solubility enhancement of poorly water soluble drugs. Dr. Gupta investigated formulation and processing factors that affect the performance of solid dispersions. Dr. Gupta has several research achievements in his career including the design and completion a Master’s thesis project on formulation of polymeric nanoparticles using design of experiment approach prepared by nanoprecipitation for brain targeting, and investigation of process and formulation parameters for formulation of cocrystals entrapped in cyclodextrin complex by supercritical fluid processing.

Additionally, Dr. Gupta also played a key role in establishing hot melt extrusion and film casting technology at St. John’s University, NY and was responsible for planning and execution of a grant proposal by Catalent Pharma Solutions in the area of hot melt extrusion. He has been a recipient to various awards like NJPhAST scholarship, FDD travelship award, Catalent R&D recognition award and Modified Release Focus Group-Shering Plough travelship award at AAPS conference. Dr. Gupta has several publications to his account and has made many poster and podia presentations at international conferences. As a graduate student, Dr. Gupta also served as a Chair for AAPS Student Chapter in 2012-13 academic year.

Guest Lecture Today

Hello everyone,

We hope that everybody had a really refreshing Thanksgiving break and spent quality time with your near & dear! As they say, “you can do anything but not everything!”. So, instead of lugging your Monday with undoable tasks, please attend the Guest speaker presentation today i.e, on December 1st, 2014 at 3:30p.m-4:30p.m in the Sciarra Room.

Ph.D, Principal Scientist, Biopharmaceutics at Merck & Co. Inc.
Ph.D, Principal Scientist, Biopharmaceutics at Merck & Co. Inc.

Our guest speaker for today will be Dr. Amitava Mitra, Principal Scientist, Biopharmaceutics at Merck & Co. Inc. and his presentation covers “How to prepare for an industrial career while in a graduate program”. This presentation will be very useful for those graduate students who are trying to make a career in the Pharmaceutical Industry. Please do attend the presentation to get some hands-on career guidance. 

*Refreshments will be served