Meeting API’s Challenges with Pharmaceutical Polymers by HME

A significantly large percentage of new chemical entities (NCEs) are poorly soluble, and the industry is always on the lookout for new excipients to adapt in drug development technologies for poorly soluble compounds.

Amorphous solid dispersions (ASD) have been well recognized for improving the solubility of crystalline drugs. Among many technologies for ASD, hot melt extrusion (HME) technology is widely used across the industry for increasing solubility and bioavailability of NCEs. The excipients’ manufacturers are working together with drug manufactures to expedite the development process by introducing the innovative polymers for such technology.

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This presentation will focus on physico-chemical characteristics of polymers suited for HME, with case studies showing the improvement of bioavailability by ASD.

Dr. Shaukat Ali has over 20 years of experience in the pharmaceutical industries including 10 years at BASF, where he is supporting the solubilization platform.  Dr. Ali’s areas of expertise include drug solubilization, liposome drug delivery, controlled release and film development technologies.

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He serves the USP panel of experts for General Chapters-Physical Analysis.  He is a member of the editorial boards of American Pharmaceutical reviews, Contract Pharma, Drug Development & Delivery, Biopharma Asia (UK), International Journal of Pharmaceutical Investigation. He has authored over 25 scientific articles and is inventor/co-inventor in 14 US patents.

He received his Ph.D. in Chemistry from the City University of New York and pursued his postdoctoral interest at the University of Minnesota and Cornell University.  He is an adjunct faculty at the College of Pharmacy, University of South Florida, Tampa, FL.

Exploring Current Topics in Skin Delivery with BASF

Norman joined BASF in April 2012 to lead technical sales of the new dermatology portfolio and the development of the Skin Delivery Platform at the new Tarrytown Dermatology lab.

Prior to BASF, from 2001 to 2011 he led innovation projects to find new opportunities within Topical Health Care at J&J and at Pfizer Consumer Healthcare. Brands he supported were Neosporin, Band-Aid, BenGay, Cortizone 10, Purell and Desitin. He also managed the medical device design control process for topical OTC medical devices and provided technical support to solve problems. From 2008-2011 Norm was a key scientist in the Technology Platforms group leading projects to scout for, identify, and evaluate technologies for topical healthcare applications, with a focus on wound care for the Band-Aid Brand and Red Cross First Aid brand.

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From 1988-2001 Norman worked for Unilever Research at the Edgewater NJ Lab to support brands such as Dove personal cleansing bars, Lever 2000, Vaseline Intensive Care lotions and other skin care products. He worked on projects investigating the metabolic fate of fatty acids deposited on skin, the regulation of epidermal hyperplasia, skin deposition of antimicrobials, biomechanics of stratum corneum and effects of hydration, water behavior in topical products, cellulite and fat metabolism and product physical chemistry (e.g. phase behavior, rheology, water activity, etc.).

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Prior to Unilever, Norman worked in the Lymphokine Biology Dept. at the New York Blood Center focusing on elucidating the effects of Interferon and Tumor Necrosis Factor on cancer cells. Norm earned his MS at Fairleigh Dickinson University and a BS at Montclair State College, where he conducted research in microbiology and protozoology.

 

 

Difficulties mastered are opportunities won.

“The number of novel compounds going into the market is decreasing as well as trends changing from highly soluble to less soluble drugs”. This was the opening statement made by Dr. David Harris, a fellow at Merck as well as a formulation scientist with over 20 years experience in the development of new chemical entities.

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These trends he said have led to the need for a highly collaborative process in Oral development programs which in turn has created a laundry of opportunities for young graduating scientists within industry. Opportunities in areas such as per formulation analysis, pre clinical compound assessments, discovery, API development  just to mention but a few are available to young scientists.

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Dr. Harris  followed these statements with a presentation on oral development Programs and what they entail.
He talked about key elements of these programs which are classified around the physical and chemical properties of the oral compound to be developed.
Amongst such properties, he mentioned the importance of stability testing, degradation mechanism studies, accelerated stability studies as well as extreme conditions stability testing which is important for drugs that will go through shipping excursions. Dissolution tests more so, bio relevant dissolution studies and clinical bio comparison are all studies that need to be undertaken in developing oral formulations.
From the above Dr. Harris clearly showed that a priori of prediction of bio performance of a drug is needed before the product is marketed. He however made it clear that most products do not make it to market as success in these studies has presented a challenge to many pharmaceutical companies thus only a few drugs actually manage to hit the market and stay in market.
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Dr. Harris further went onto talking about various solid dispersion formulations and hot melt extruded solid dispersion’s giving some knowledge on why such formulations are preferred for development.
He also talked about the optimization of blend flow with respect to composition and processing of the formulation (the API and its attributes). From this he gave a comparison of spray dried and hot melt extrusion preparations in relation to their compression properties and costs of production.  He stressed the importance of establishing robustness to variations of API and excipient attributes. Optimization, he added is a very important exercise to undertake in this respect.
Dr. Harris concluded his discussion by presenting a number of case studies undertaken in the oral development program.
We thank this brilliant scientist for making time to come and speak with us.

Guest lecture to Kick off 2014 academic year!

Our first guest lecture for the spring 2014 semester was given by Jian- Xin Li, Ph.D. and technical manager at DFE Pharma North America. DFE Pharma is a company that deals with the development, production and marketing of pharmaceutical excipients for oral solid dosage and dry powder inhalation.
Dr. Jian-Xin  termed it an honor to be giving a presentation at the school in front of his hero Dr. Serajuddin. He spoke in depth about the manufacturing of bi layer tablets. The guest speaker was enthused by the positive interactions and contributions he received from the students during the lecture. The session was interactive and informative been a follow up from a previous presentation we students had during journal club. The lecture served to reinforce our knowledge on bi layer tablets.
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The presentation was followed by a brief QnA session in B2.  The lecture concluded with a word of appreciation from our very own Professor Dr. Serajuddin who also presented our guest with a certificate of appreciation and a little token. We thank Dr. Jian – Xin Li for the gifts he also brought for the attendees of the guest lecture and for his time to speak to us and increase our knowledge on bi layer tablets. We hope to have him back soon.
For the powerpoint on bi layer tablets and the manufacture of primojel please click below.

The better the powder, the sounder the tablet.

Our last guest lecture held on the 20th of November 2013 was one intimate and interactive affair. The lecture was given by a budding scientist,  Mr. John Yin who currently works for Freeman Technology, a powder characterisation company based in New York.

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Mr. Yin stands by an FT4 Powder Rheometer.

Mr. Yin coupled his knowledge from years of surface chemistry and powder characterisation with an instrument demonstration during the workshop. He demonstrated the use of the FT4 Universal Powder Rheometer in powder processing, the applications of which include measurement of hopper flow, mixing & blending, filling and compression. With the demonstration in process, Mr. Yin explained why we need to measure powder characteristics and flow properties in particular.

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Mr. Yin making his presentation as students attentively look on.

During his presentation, he gave an overview of some powder processing challenges in pharmaceutical industries. Mr. Yin also touched on the fundamentals of particle interaction and the need to identify Critical Quality attributes in relation to formulation and process optimization. From the knowledge shared, we learnt that a formulator can measure, predict and eliminate common tablet processing issues such as rat-holing, bridging, sticking, segregation, lamination & capping and attrition.

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Former AAPS chair Mr. Parikh presents Mr. Yin with a token of appreciation

We hope to have Mr. Yin back for another guest lecture.

The SJUAAPS would like to thank the students for their active participation in all the activities that the chapter organised this semester. We hope to have much more lined up for you come Spring 2014! Success as you prepare for your finals and Happy Holidays from the SJUAAPS committee.

More than just Coffee.

Conversation, coffee and treats were some of the pleasantries shared at the first coffee hour by the SJU AAPS Student Chapter. The interpersonal session was created by the committee to give students a chance to address issues they face that may not be addressed during lecture hours, lab hours or meeting with their mentors.  It was an honor to have one of our own faculty, Dr Emilio Squillante as our guest.

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Treats prepared by Sayma Monir

The charismatic doctor was presented with a laundry of questions from the student body which he addressed with wit. He made the session an open and interactive one with students chipping in on issues from academic life to career goals as well as student/faculty relationships and rapport.  The professor of Pharmaceutics emphasised the importance of being goal driven. This he said will give a student the drive necessary to see the successful completion of his/her thesis despite the hurdles research may often present.

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Attentive students sit around Dr. Squillante as he reads out a question.
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An enthusiastic conversation it was.

When it came to career and marketability, Dr. Squillante  simply said that we should ‘fish where people aren’t fishing’. He added that a good start for entrepreneurial opportunities in Pharma is to work with the FDA. Excipient suppliers and companies dealing with technical pharma support he added were some of the best networks and contacts for one to have under their belt once out of school. He urged the students to actively participate in workshops, seminars, NJPhAST meetings, industrial tours, internships and pharmaceutical networking events to be able to get their feet into the market.

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Our chairman, Pulkit Khatri presents a certificate of appreciation to Dr. Squillante on behalf of the SJU AAPS.

We appreciate the time Dr. Squillante took out of his schedule to share his wisdom and acumen on pharmaceutical academia and industry with us. We hope to have him back for another coffee hour.

Drug Excipient Interactions are a mainstay in drug formulation development

Last Wednesday, our graduate students were inspired by our recent guest speaker Dr. Manpreet Kaur, who spoke about fundamentals in new drug development and drug delivery research. Dr. Kaur contributed to an outstanding four NDA (New Drug Applications) in her 8 years of experience as a formulator, out of which two new drugs already made it through intense scrutiny by US-FDA into US pharmaceutical market. The topic for the presentation was focused on drug-excipient interactions that are commonly seen in drug formulation development. Dr. Kaur’s presentation was comprehensible and well explained.

Her presentation focused on the importance of paying attention to the API and excipients used in drug products through chemistry, manufacturing and control. She gave students an outline of the journey that a drug goes through from pre-clinical feasibility tests, that are mainly carried out by academia right through to the FDA filling and approval of the drug.  Dr. Kaur said that the API and excipients may change their form through any of the processes and that it is paramount that the formulator makes sure that this does not happen.

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Graduate students taking notes

In the discussion Dr. Kaur mentioned that as a student she was given a question at her thesis defense that she has never forgotten and which she talked about. The question was to differentiate between bound and unbound water. From this she highlighted the role of water in affecting product stability. She mentioned some stabilizing methods that formulators are using to decrease unfavorable incompatibilities. Some mitigation strategies she added may be used to decrease drug excipient interactions such as  prior investigation of possible API changes, API/Excipient ratios as well as packaging considerations.

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The SJU AAPS committee and students showed their appreciation for Dr. Manpreet Kaur’s time and presentation by presenting her a certificate and token. We wish her all the best in her career and research endeavors.

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Secretary of SJU AAPS, Mayuri Borsadia presents Dr. Kaur a certificate (above) and a token of appreciation on behalf of our chapter

Our Student Chapter attracts new members at Pharmacy Organization Day

With the incoming of eager and curious freshmen, the College of Pharmacy and Health Sciences put together a Pharmacy Organization Day. October 24 from 9 AM onwards witnessed the presence of students and representatives from many diverse pharmacy organizations on campus, National and State Associations, and student chapter affiliates, at the Human Educational Resource Center.

SJU AAPS Student Chapter Booth
SJU AAPS Student Chapter Booth

This day was specifically aimed to acquaint our new students to various organizations that exist within the School of Pharmacy and the prospects of active participation in such professional organizations in development and structuring of their career as future pharmacists. Some of the organizations include the NYS Council of Health System Pharmacist Chapter, the Pharmacist Society of the State of New York and affiliates, and the American Society of Consultant Pharmacists.

Students showing their interest in AAPS Student Chapter at St. John's
Students showing their interest in AAPS Student Chapter at St. John’s

The St. John’s AAPS Students chapter had as much to showcase our wide array of activities of guest speaker scientists, equipment workshops, coffee hours, NJPhAST networking and nonetheless public spirited events.  “We aim to encourage as many pharmacists to get involved in our group. Today our chapter attracted over a 100 new members. We are truly thankful to Jackie (Jaclyn Vialet), Director of HERC, who has supported us immensely to make such a success possible for our chapter” quoted our committee chair Pulkit Khatri. The students in the fair seemed very impressed with our professional platform and we topped it up with some exciting give-aways.

All in all, it was very satisfying to see the growth of the chapter and that we are making a difference in the professional lives of our members!

AAPS student chapter stands tall on humanitarian forefront.

October 19, 2013 witnessed a remarkable event for AAPS Student Chapter as we participated in New York Cares Day. Our figureheads at College of Pharmacy, Associate Dean Sawanee and Associate Professor Dr. Jun Shao took an initiative to organize a group of about 40 enthusiastic volunteers to work at a public school 282 Q in Far Rockaway, New York. A day’s work was shown by visible improvements at the school and happy volunteers. The student volunteers started the day nice and early at 8 am from St. John’s University and proceeded forward to support the cause. Dean Sawanee, did not just initiate this cause but also took great care of our student volunteers on their mission. cca4c8677faa43bebed2370eaec2b366On reaching at 282 Q, the school authorities and New York Cares Day volunteers gave our team a warm welcome and some exciting give-away gifts as a token of appreciation. Our supervisor Dr. Shao split us into 3 groups, each assigned a different activity. The teams did a wonderful job of painting canvas murals of school logo, motto and other inspirational quotes. Hallways and staircases touch ups gave a new shine to the school.

Screen Shot 2013-10-23 at 8.43.55 PMRe-organizing the many closets and the stationary supplies was personally seen by Dr. Shao who is not only a great scientist but also inspired us with his great sense of compassion. The day ended with a satisfaction filled in hearts of student volunteers for having re-lived human values of selflessness.

Truly, an exciting job and a noble cause! We wish for more of these to enrich the lives of our young scientists.

Focus on Quality by Design and save a dollar

“If you paid more attention to the excipients you used, you would spend less money on  processing a batch of tablets,” Mr. Ken Seufert, Managing Director, North America for MEGGLE USA Inc. said. Meggle is a leading manufacturer of a wide range of lactose grades for solid dosage forms and unique co-processed excipients for direct compression as well as speciality products for dry powder inhalers.

Mr. Parikh gives a short lecture on principles of operation of a rheometer.
Mr. Parikh gives a short lecture on principles of operation of a rheometer.

The AAPS Student Chapter welcomed Mr. Seufert who gave a lecture on “The Economic impact of QbD and other considerations on formulation development.” The presentation which took off with an open round table discussion was held on the  16th of October 2013 in Sullivan hall. Mr. J. Zeleznik, Manager Technical and Regulatory affairs, Meggle was also present to reinforce the words of Mr. Seufert.

He urged the students to ‘think outside the box’ when it comes to product development. This he said will lead to better financial outcomes. 

Mr. Seufert is introduced by SJU AAPS Chair-Elect, Neha Chavan.
Mr. Seufert is introduced by SJU AAPS Chair-Elect, Neha Chavan.

We the AAPS Student Chapter thank Mr. Seufert and Mr. Zeleznik for taking out their time to come and share with us.  We hope to be dollar smart formulators!!

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SJU AAPS Vice Chair, Ms.Gobbooru presents a certificate of appreciation to Mr. Seufert.

For Mr. Seufert’s presentation slides click here