Research Groups

Dr. Mutasem Qalaji's Research Team: Nanotechnology, Formulation and Drug Delivery

Research Interests: Nanoparticles, Nanocrystals, Orally Disintegrating Tablets (ODT), Drug Release, Dissolution, Absorption, Bioavailability, Non-invasive and patient-friendly drug delivery approach.

Dr. Mutasem Qalaji's Research Team

From left: Annette Losada, B.Sc. (Pharm.D. student, class of 2015), Mutasem Rawas-Qalaji, B.Pharm., Ph.D (assistant professor or pharmaceutical sciences, College of Pharmacy, Nova Southeastern University), Alhusain Odah, B.Pharm. (Ph.D. student), Belacryst Mandez (Pharm.D. student, class of 2015)

Current Research

Reversed Micelles Platforms
1. Fabrication, characterization, and evaluation of reversed micelles as a novel delivery platform for antitumor metalodrugs for potential treatment of cancer.
  - In collaboration with Professor Michael Johnson and Dr. David Richens and their teams an R15 NIH proposal has been submitted June 25, 2012.
Nanoparticles Platforms
1. Nanocrystals fabrication and characterization of epinephrine using high shear fluid processor
  - Project is under progress. Current results are very promising. Epinephrine nanocrystals fabrication was successful using this novel technique and resulted in stable, uniform, and reproducible epinephrine nanocrystals at the nano size-range after a single pass.
  - Detailed technique and results were successfully filed by Technology Transfer Office at Nova Southeastern University for Provisional US Patent Application on June 15, 2012.
  - A manuscript is under preparation to be submitted for publication in a peer-reviewed journal.
Drug Release Studies
1. Quantification and evaluation of xylitol release from baby tooth wipes for the potential prevention of dental carries in infants.
  - Project was in collaboration with the College of Dental Medicine. The amount of xylitol contained in Baby Tooth wipes, the maximum amount released, and the time required to be released were determined. Recommendations to dentist about the usefulness and the frequency of application of these wipes were achieved.
  - Abstract was accepted and poster was presented during the American Academy of Pediatric Dentistry (AAPD) Annual Session, San Diego, CA (May 24-27, 2012).
  - The results were presented through a podium presentation during the Research Day, College of Dental Medicine - Nova Southeastern University, May 14, 2012.
  - A manuscript is under preparation to be submitted for publication in a peer-reviewed dental journal.
Diffusion Studies
1. In-vitro and Ex-vivo diffusion of epinephrine nanoparticles from a novel orally disintegrating tablet dosage form for the first-aid treatment of anaphylaxis
  - Project is under progress. Results obtained will be used to establish ex vivo/in vivo correlation.
2. In-vitro diffusion of amlodipine nanoparticles from a novel orally disintegrating tablet dosage form for the treatment of hypertension
  - Project is under progress in collaboration with Dr. Enrique Nieves.
Formulation Studies
1. Formulation and evaluation of a novel orally disintegrating epinephrine tablets using various superdisintegrats for the first-aid treatment of anaphylaxis
  - Project is partially completed and still under progress.
Bioavailability Studies
1. Bioavailability of sublingually administered epinephrine nanocrystals formlated as orally disintegrating tablets for the first-aid treatment of anaphylaxis
  - Project is under progress.
2. Bioavailability of sublingually administered taste-masked, orally disintegrating epinephrine tablets for the first-aid treatment of anaphylaxis
  - Results showed that the taste-masked and flavor-enhanced new formulation of 40 mg epinephrine ODT was bioequivalent to EpiPen® intramuscular injection.
  - Detailed study design and results were successfully filed by Technology Transfer Office at Nova Southeastern University for Provisional US Patent Application on June 15, 2012.
  - Abstracts were published in AAPSJ and posters were presented during the
    - American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Chicago, IL (Oct 14-18, 2012).
    - Collegium Internationale Allergologicum (CIA), Jeju Island, South Korea (Oct 16-19, 2012).
  - A manuscript is in press for publication in J Allergy Clin Immunol.
Stability Studies
1. Evaluation of long-term stability of novel orally disintegrating epinephrine tablets at various storage conditions for the first-aid treatment of anaphylaxis
  - Results showed that epinephrine was stable in this novel ODT formulation for at least 7 years versus the 12-18 months shelf-life for epinephrine autoinjectors.
  - Detailed study design and results were successfully filed by Technology Transfer Office at Nova Southeastern University for Provisional US Patent Application on June 15, 2012.
  - Abstract was accepted and poster will be presented during the American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Chicago, IL (Oct 14-18, 2012).
  - A manuscript is under preparation to be submitted for publication in a peer-reviewed journal.

Previous Research

Nanoparticles Platforms
1. Nanoparticles fabrication and characterization of epinephrine using synthetic biodegradable polymers
  - Procedure used was successful and fabrication yield was high, however, encapsulation efficiency was extremely low.
2. NP fabrication and characterization of epinephrine using natural biodegradable polymers
  - Promising results were obtained. Procedure used was efficient and reproducible. By adjusting several variables, high encapsulation efficiency and fabrication yield at small nanosize range can be achieved.
  - Detailed technique and results were successfully filed by Technology Transfer Office at Nova Southeastern University for Provisional US Patent Application on Oct 21, 2011, and was converted to International Patent Application on Oct 19, 2012.
  - Abstract was published in AAPSJ and poster was presented during the American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Washington, DC (Oct 23-27, 2011).
  - Podium presentation of the obtained results was presented during the Research Day, College of Pharmacy- Nova Southeastern University, Feb 10, 2012.
  - Abstract was published in AAPSJ and poster was presented during the American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Chicago, IL (Oct 14-18, 2012)
3. Preliminary NP fabrication and characterization of epinephrine base and salt using high shear fluid processor
  - The particles size f epinephrine base was reduced to nano size-range. Particles size of epinephrine salt was reduced to over 60 times of it original size. The obtained size was in the micro size-range. Only epinephrine salt was stable during the process.
  - Detailed technique and results were successfully filed by Technology Transfer Office at Nova Southeastern University for Provisional US Patent Application on Mar 1, 2010 and was converted to International Patent Application on Mar 1, 2011. In 2012, US Patent Application was filed on Aug 31, 2012.
  - Abstract was accepted and poster was presented during the NanoFlorida 2011, The 4th Annual NanoScience Technology Symposium, Miami, FL (Sep 30-Oct 1, 2011).
  - Abstract was accepted and poster was presented during the Association of Pharmacists of PR Meeting, Fajardo, PR (Aug 23 - 25, 2012).
Diffusion Studies
1. In-vitro diffusion of preliminary epinephrine base nanoparticles for the first-aid treatment of Anaphylaxis
  - In-vitro results demonstrated significant increase in epinephrine base diffusion.
  - Detailed study design and results were successfully filed by Technology Transfer Office at Nova Southeastern University for Provisional US Patent Application on Mar 1, 2010 and was converted to International Patent Application on Mar 1, 2011. In 2012, US Patent Application was filed on Aug 31, 2012.
  - Abstract was published in JPPS and poster was presented during the Canadian Society of Pharmaceutical Sciences (CSPS) Annual Symposium, Vancouver, Canada (Jun 2-5, 2010).
Dissolution Studies
1. Designing, fabrication, and evaluation of a novel dissolution apparatus for orally disintegrating tablets
  - A dissolution apparatus was successfully fabricated and qualified. Results showed that this apparatus was superior to USP apparatus in discriminating between different ODT formulations.
  - Detailed dissolution apparatus design and results were successfully filed by Technology Transfer Office at University of Manitoba for Provisional US Patent Application on Nov 1, 2008.
  - Detailed dissolution apparatus design and results were also published in AAPS PhamSciTech, 2011 Jun;12(2):544-52.
  - Abstracts were published in AAPSJ and posters were presented during the American Association of Pharmaceutical Scientists (AAPS) Annual Conference in
    - Atlanta, GA (Nov 16-20, 2008).
    - San Diego, CA (Nov 10-15, 2007).
    - San Diego, CA (Nov 10-15, 2007).
Formulation Studies
1. Development of a novel taste masked, orally disintegrating epinephrine tablets for the first-aid treatment of anaphylaxis.
  - Detailed formulation design and testing results were successfully filed by Technology Transfer Office at Nova Southeastern University for Provisional US Patent Application on Oct 21, 2011, and was converted to Internation Patent Application on Oct. 19, 2012.
  - Detailed formulation design and testing results were also published in Eur J Pham Biopharm, 2012 June 7 (Epub ahead of print). DOI: 10.1016/j.ejpb.2012.05.020.
  - Abstract was published in AAPSJ and poster was presented during the American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Washington, DC (Nov23-27, 2011).
2. Evaluation of the taste of epinephrine and effectiveness of various taste masking and flavor enhancing excipients using electronic tongue
  - We were able to mask the bitter taste of epinephrine using various excipients.
  - Detailed study design and evaluation results were published in AAPS PhamSciTech, 2010 Jun;11(2):550-7.
3. Ocular controlled-release formulations (hydrogels, biodegradable implants, intravitreal and subconjuctival injections, nanoparticles)
  - Results from these various studies are proprietary for QLT, Inc.
  - A review article about Ocular Drug Delivery was published in Curr Eye Res, 2012; 37(5):345-56.
4. Formulation and evaluation of the physical properties of novel orally disintegrating epinephrine tablets for the first-aid treatment of anaphylaxis
  - Formulation and extensive quality control evaluation of epinephrine ODT was accomplished for the first time.
  - Detailed formulation design and testing results were successfully filed by Technology Transfer Office at University of Manitoba for US Provisional US Patent Application on Sep 9, 2005, and was converted to US Patent Application on Sep 8, 2006 and International Patent Application on Sep 8, 2006.
  - Detailed formulation design and testing results were also published in
    - AAPS PhamSciTech, 2006; 7(2):E41.
    - Drug Dev Ind Pharm, 2007; 33(5):523-30.
  - Abstracts were published in AAPSJ and posters were presented during the American Association of Pharmaceutical Scientists (AAPS) Annual Conference in
    - Nashville, TN (Nov 6-10, 2005).
    - Baltimore, MD (Nov 7-10, 2004).
    - Baltimore, MD (Nov 7-10, 2004).
Bioavailability Studies
1. In vivo evaluation of biopharmaceutical factors affecting epinephrine sublingual absorption and bioavailability
  - Were able to show in vivo the effect of formulation excipients on drug absorption and bioavailability.
  - Detailed study design and results were published in Biopharm Drug Dispos, 2006; 27(9):427-35.
  - Abstract was published in AAPSJ and poster was presented during the American Association of Pharmaceutical Scientists (AAPS) Annual Conference, San Antonio,TX (Oct 29-Nov 2, 2006).
2. Dose-ranging, proof of concept bioavailability studies of sublingually administered orally disintegrating epinephrine tablets for the first-aid treatment of anaphylaxis
  - Were able for the first time to deliver epinephrine sublingually and determine the bioequivalent dose of sublingual epinephrine to EpiPen®.
  - Detailed formulation design and testing results were successfully filed by Technology Transfer Office at University of Manitoba for US Provisional US Patent Application on Jan 17, 2006, and was converted to US Patent Application on Feb 7, 2007 and International Patent Application on Feb 7, 2007 .
  - Detailed study design and results were also published in J Allergy Clin Immunol, 2006; 117(2):398-403.
  - Podium presentation of the obtained results was presented during Allergy session in the American Academy of Allergy Asthma and Immunology (AAAAI) Annual Meeting, Miami Beach, Florida (Mar 3-7, 2006).
  - Abstract was published in J Allergy Clin Immunol and poster was presented during the Academy of Allergy Asthma and Immunology (AAAAI) Annual Meeting, Miami Beach, Florida (Mar 3-7, 2006).
Stability Studies
1. Evaluation of the stability of epinephrine sublingual tablets for the first-aid treatment of anaphylaxis
  - The stability of epinephrine was evaluated in buffer and human saliva, and tablets were evaluated at various extreme storage conditions.
  - Abstracts were published in AAPSJ & J Allergy Clin Immunol and posters were presented during the
    - American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Baltimore, MD (Nov 7-10, 2004).
    - American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Nashville, TN (Nov 6-10, 2005).
    - Academy of Allergy Asthma and Immunology (AAAAI) Annual Meeting, San Diego, CA (Feb 23-27, 2007).
2. Evaluation of the stability of epinephrine in pre-filled syringes under extreme storage conditions for the first-aid treatment of anaphylaxis
  - We were able to show for the first time that epinephrine stored in pre-filled, unsealed syringes is stable for at least 3 months under extreme storage conditions. Also, several stability studies under elevated temperatures and for out-dated epinephrine auto-injectors were completed.
  - Detailed study design and results were published in Ann Allergy Asthma Immunol, 2009; 102(6):500-3.
  - Abstracts were published in AAPSJ & J Allergy Clin Immunol and posters were presented during the
    - American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Salt Lake City, UT (Oct 26-30, 2003).
    - American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Baltimore, MD (Nov 7-10, 2004).
    - Academy of Allergy Asthma and Immunology (AAAAI) Annual Meeting, San Antonio, TX (Mar 18-22, 2005).
    - American Association of Pharmaceutical Scientists (AAPS) Annual Conference, New Orleans, LA (Nov 14-18, 2010).
    - Academy of Allergy Asthma and Immunology (AAAAI) Annual Meeting, San Francisco, CA (Mar 18-22, 2011).
    - American Association of Pharmaceutical Scientists (AAPS) Annual Conference, Washington, D.C. (Oct 23-27, 2011).
    - Academy of Allergy Asthma and Immunology (AAAAI) Annual Meeting, Orlando, FL (Mar 2-6, 2012).

Collaborators

Mutasem Rawas-Qalaji, B. Pharm., Ph.D, Ousama Rachid, M.Sc., B. Pharm., Keith Simons, Ph.D.

Canadian Team - University of Manitoba:
Dr. Qalaji's Lab collaborates with Professor Keith Simons and his team at the Faculty of Pharmacy, University of Manitoba, Winnipeg, Canada.
Dr. Simons is a well-known scientist in the field of pharmacokinetics.
In the picture from left: Mutasem Rawas-Qalaji, B. Pharm., Ph.D (Assistant professor, College of Pharmacy, Nova Southeastern University), Ousama Rachid, M.Sc., B.Pharm. (Ph.D. Candidate, University of Manitoba), Keith Simons, Ph.D. (Professor, Faculty of Pharmacy, University of Manitoba)

Chemistry Team - New Mexico State University:
Recently, Dr. Qalaji's Lab started collaborating with Professor Michael Johnson and his team at Department of Chemistry & Biochemistry, New Mexico State University, Las Cruces, NM.
Dr. Johnson is an expert in the area of encapsulating metal complexes.

Puerto Rico Team - Nova Southeastern University:
Dr. Qalaji's Lab collaborates with Dr. Enrique Nieves and his team at the College of Pharmacy, Nova Southeastern University in Ponce site, Puerto Rico.
Dr. Nieves has significant industrial experience.

Mutasem Rawas-Qalaji, B. Pharm., Ph.D and Daniel Yoo, DMD Pharm., Ph.D

Dentistry Team - Nova Southeastern University:
Dr. Qalaji's Lab collaborates with the College of Dental Medicine's faculty advisors at Nova Southeastern University, FL.
Dr. Daniel Yoo, Pediatric Dental Resident, conducted his residency research project and got trained in Dr. Qalaji's Lab.
In the picture from left: Mutasem Rawas-Qalaji, B. Pharm., Ph.D (Assistant professor, College of Pharmacy, Nova Southeastern University), Daniel Yoo, DDS (Pediatric Dental Resident, College of Dental Medicine, Nova Southeastern University)

Trained Students

Alhussain Aodah, B.Pharm.

Alhussain joined College of Pharmacy at Nova Southeastern University as a Ph.D. student in the Drug Development (Pharmaceutics) track in 2011.
Alhussain earned his B. Pharm. from King Saud University (KSA, 2008), and worked as a pharmacist in Security Force Hospital for one year, then joined Salman bin Abdulaziz University as Teaching Assistant.

Belacryst Mendez (Pharm.D. Student, Class 2015)

Belacryst joined College of Pharmacy at Nova Southeastern University as a Pharm.D. student in 2011.
Belacryst has been trained in Dr. Qalaji's Lab to perform diffusion studies, dissect mucosal membranes from pigs, fabricate drug-loaded nanoparticles using ionic gelation method and high sheer fluid process, measure nanoparticles/nanocrystals size and potential, perform FTIR scanning, use HPLC, manufacture tablets, and use lab notebook.
Belacryst is a coauthor of one peer-reviewed abstract that has been presented as a poster presentation during AAPS Annual Conference in Chicago, IL (Oct 14-18, 2012) and will be published in peer-reviewed AAPS journal.

Annette Losada and Belacryst Mendez (Pharm.D. students, Class 2015) dissecting and excising sublingual mucosal membrane from pigs.

Annette Losada, B. Sc. (Pharm.D. Student, Class 2015)

Annette joined College of Pharmacy at Nova Southeastern University as a Pharm.D. student in 2011.
Annette has been trained in Dr. Qalaji's Lab to perform diffusion studies, dissect mucosal membranes from pigs, fabricate nanoparticles using ionic high sheer fluid process, measure nanocrystals size and potential, use HPLC, manufacture tablets, and use lab notebook.

Noor Daghistani, B. Sc. (Pharm.D. Student, Class 2014)

Noor joined College of Pharmacy at Nova Southeastern University as a Pharm.D. student in 2010.
Noor has been trained in Dr. Qalaji's Lab to perform diffusion studies, fabricate drug-loaded nanoparticles using ionic gelation method, measure nanoparticles size and potential, perform HPLC analysis, and use lab notebook.
Noor is a coauthor of one peer-reviewed abstract that has been presented as a poster presentation during AAPS Annual Conference in Chicago, IL (Oct 14-18, 2012) and will be published in peer-reviewed AAPS journal.

Mutasem Rawas-Qalaji, B. Pharm., Ph.D, Noor Daghistani, Pharm.D., and Keith Simons, Professor, Faculty of Pharmacy, University of Manitoba

Noor Daghistani, B. Sc. (Pharm.D. Student, Class 2014) presenting during AAPS Annual Conference in Chicago, IL (Oct 14-18, 2012).
In the picture from left: Mutasem Rawas-Qalaji, B. Pharm., Ph.D (Assistant professor, College of Pharmacy, Nova Southeastern University), Noor Daghistani, B. Sc. (Pharm.D. Student) and Keith Simons (Professor, Faculty of Pharmacy, University of Manitoba).

Bibi Khan, B. Sc. (Pharm.D. Student, Class 2013)

Bibi joined College of Pharmacy at Nova Southeastern University as a Pharm.D. student in 2009.
Bibi has been trained in Dr. Qalaji's Lab to manufacture and evaluate ODT tablets, perform HPLC analysis, and use lab notebook.

Khyati Desai, Pharm.D. (International Class 2011)

Khyati joined College of Pharmacy at Nova Southeastern University as a Pharm.D. student in 2008.
Khyati has been trained in Dr. Qalaji's Lab to fabricate drug-loaded nanoparticles using ionic gelation, and emulsion-solvent evaporation methods, measure nanoparticles size and potential, perform FTIR scanning, perform HPLC analysis, and use lab notebook.
Khyati is a coauthor of two peer-reviewed abstracts that have been published in peer-reviewed journals (JPPS and AAPSJ) and were presented as poster presentations in:
- AAPS Annual Conference in Washington, DC (Oct 23-27, 2011)
- CSPS Annual Symposium in Vancouver, Canada (Jun 2-5, 2010)
Khyati presented during AAPS Annual Conference in Washington, DC (Oct 23-27, 2011) and was recognized for her presentation in SharkBytes News Letter of NSU in Nov 14, 2011.

Khyati Desai, Pharm.D. and Mutasem Rawas-Qalaji, B. Pharm., Ph.D

Khyati Desai, Pharm.D. (International Class 2011) and Mutasem Rawas-Qalaji, B. Pharm., Ph.D ( Assistant professor, College of Pharmacy, Nova Southeastern University) presenting during AAPS Annual Conference in Washington DC (Oct 23-27, 2011).

Jason Stubblefield (Pharm.D. Student, Class 2012)

Jason joined College of Pharmacy at Nova Southeastern University as a Pharm.D. student in 2008.
Jason has been trained in Dr. Qalaji's Lab to fabricate drug-loaded nanoparticles using double emulsion-solvent evaporation methods, measure nanoparticles size and potential, perform HPLC analysis, and use lab notebook.
Jason is a coauthor of one peer-reviewed abstract that has been published in peer-reviewed JPPS journal and was presented as poster presentation during CSPS Annual Symposium in Vancouver, Canada (Jun 2-5, 2010)

Nandita Koodie (Pharm.D. Student, Class 2012)

Nandita joined College of Pharmacy at Nova Southeastern University as a Pharm.D. student in 2008.
Nandita has been trained in Dr. Qalaji's Lab to fabricate drug-loaded nanoparticles using emulsion-solvent evaporation methods, measure nanoparticles size, perform HPLC analysis, and use lab notebook.

Major Research Equipment

From Top-Left: High Performance Liquid Chromatography (HPLC) with PDA and Electrochemical Detector (Waters), HPLC with ultraviolet detector (UV) (PerkinElmer), Fourier Transform Infrared Spectroscopy (FTIR, PerkinElmer), Differential Scanning Calorimetry (DSC 4000) with Thermogravimetric Analyzers (TGA 4000) (PerkinElmer), Sonifier 450 Analog (Branson), L4R Laboratory High Shear Mixer (Silverson), MicroFluidizer LV1 (Microfluidics), Nanosizer (Malvern), Mastersizer (Malvern), UV-1700 Spectrophotometer (Shimadzu), Avanti-J25 and L7 Ultrcentrifuge (Beckman), Fume Hood, NanoPur System (Barnstead), Allegra 21R Centrifuge (Beckman Coulter), Bench Top Freeze Dryer (ART), Flow-Through Vertical Franz Cell Diffusion Automated System and Static Vertical Franz Cell Diffusion System (PermeGear), Rotary Tablet Press (Colton), Hardness tester LIH-3 (Vanguard), USP Friability Tester LIC-1 (Vanguard), V-Shape Powder Mixer, USP Dissolution Apparatus (Type I and II) (Varian), Bath Sonicator/Degasser (Branson), Multivortexer (VWR) and Vortexer (Fisher), Temperature-Controlled shaker (Forma Scientific), Lab pictures.

Recognitions

President's Faculty Research Award was presented by Ray Ferrero, Ph.D. (President of Nova Southeastern University), in the center, and Andres Malave, Ph.D. (Dean of College of Pharmacy at Nova Southeastern University), on the left, in 2010 to Mutasem Rawas-Qalaji, B.Pharm., Ph.D (Assistant professor, College of Pharmacy, Nova Southeastern University), on the right.

Recognition Award was presented by Khaled Al-Hamoud, Ph.D. (President of Ebla University), on the left, in 2010 to Mutasem Rawas-Qalaji, B.Pharm., Ph.D (Assistant professor, College of Pharmacy, Nova Southeastern University), on the right.

Patents, Publications and Presentations

Intellectual Properties

Rawas-Qalaji MM, Simons KJ, Gu X, Simons ER. Fast-Disintegrating Epinephrine Tablets for Buccal or Sublingual Administration. US Provisional Patent Application # 60/715,180. Filed Sep. 9, 2005. Assignee: University of Manitoba.
Rawas-Qalaji MM, Simons KJ, Gu X, Simons ER. Fast-Disintegrating Epinephrine Tablets for Buccal or Sublingual Administration. US Provisional Patent Application # 60/759,039. Filed Jan. 17, 2006. Assignee: University of Manitoba.
Rawas-Qalaji MM, Simons KJ, Gu X, Simons ER. Fast-Disintegrating Epinephrine Tablets for Buccal or Sublingual Administration. US Patent Application # 20070059361. Filed Sep. 8, 2006 and published March 15, 2007. Assignee: University of Manitoba (licensed April, 2006).
Rawas-Qalaji MM, Simons KJ, Gu X, Simons ER. Fast-Disintegrating Epinephrine Tablets for Buccal or Sublingual Administration. International Patent Application (WIPO) # PCT/CA2006/001472, Filed Sep. 8, 2006 and published March 03, 2007. Assignee: University of Manitoba (licensed April, 2006).
Rawas-Qalaji MM, Simons KJ, Gu X, Simons ER. Fast-Disintegrating Epinephrine Tablets for Buccal or Sublingual Administration. US Patent Application #20070202163. Filed Feb. 7, 2007 and published August 30, 2007. Assignee: University of Manitoba (licensed April, 2006).
Rawas-Qalaji MM, Simons KJ, Gu X, Simons ER. Fast-Disintegrating Epinephrine Tablets for Buccal or Sublingual Administration. International Patent Application (WIPO) # PCT/CA2008/000197, Filed Jan. 31, 2008 and published August 14, 2008. Assignee: University of Manitoba (licensed April, 2006).
Rachid OM, Rawas-Qalaji MM, Simons ER, Simons KJ. Novel Dissolution Apparatus Designed to Evaluate Sublingual Tablets. Provisional US Patent Application. Filed Nov 1, 2008. Assignee: University of Manitoba
Rawas-Qalaji MM, Nieves E., Simons KJ, Simons ER, Rachid OM. Composition and Method for Emergency Treatment of Anaphylaxis. Provisional US Patent Application # 61/309,136. Filed March 1, 2010. Assignee: Nova Southeastern University
Rawas-Qalaji MM, Nieves E., Simons KJ, Simons ER, Rachid OM. Epinephrine Nanoparticles, Methods of Fabrication Thereof, and Methods for Use Thereof for Treatment of Conditions Responsive to Epinephrine. International Patent Application (WIPO) # PCT/US2011/026604. Filed March 1, 2011 and published September 9, 2011. Assignee: Nova Southeastern University
Rawas-Qalaji MM, Rachid OM, Simons KJ, Simons ER. Epinephrine Nanoparticles Methods of Fabrication Thereof, and Methods for use Thereof for Treatment of Conditions Responsive to Epinephrine. US Provisional Patent Application, Filed October 21, 2011. Assignee: Nova Southeastern University
Rawas-Qalaji MM, Rachid OM, Simons KJ, Simons ER. Epinephrine Nanoparticles Methods of Fabrication Thereof, and Methods for use Thereof for Treatment of Conditions Responsive to Epinephrine. US Provisional Patent Application # 61/660,273, Filed June 15, 2012. Assignee: Nova Southeastern University
Rawas-Qalaji MM, Nieves E., Simons KJ, Simons ER, Rachid OM. Epinephrine Nanoparticles, Methods of Fabrication Thereof, and Methods for Use Thereof for Treatment of Conditions Responsive to Epinephrine. US Patent Application # 13/582,346. Filed August 31, 2012. Assignee: Nova Southeastern University
Rawas-Qalaji MM, Rachid OM, Simons KJ, Simons ER. Epinephrine Nanoparticles Methods of Fabrication Thereof, and Methods for use Thereof for Treatment of Conditions Responsive to Epinephrine. International Application (WIPO) # PCT/US2012/xxxxxx. Filled October 19, 2012. Assignee: Nova Southeastern University

Peer-Reviewed Journal Publications (PubMed):

Rawas-Qalaji MM, Simons ER, Simons KJ. Sublingual Epinephrine Tablets Versus Intramuscular Injection of Epinephrine: Dose Equivalence for Potential Treatment of Anaphylaxis. J Allergy Clin Immunol. 2006; 117(2):398-403. (Times Cited: 33, Impact factor: 11) DOI: 10.1016/j.jaci.2005.12.1310. PMID: 16461140. PMID: 16461140
Rawas-Qalaji MM, Simons ER, Simons KJ. Fast-Disintegrating Sublingual Tablets: Effect of Epinephrine Load on Tablet characteristics. AAPS PharmSciTech. 2006;7(2): E41. (Times Cited: 21, Impact factor: 1.4) DOI: 10.1208/pt070241. PMCID: PMC2750292.
Rawas-Qalaji MM, Simons ER, Simons KJ. Epinephrine for the Treatment of Anaphylaxis: Do all 40 mg Sublingual Epinephrine Tablet Formulations with Similar In Vitro Characteristics have the Same Bioavailability?. Biopharm Drug Dispos. 2006;27(9):427-435. (Times Cited: 5, Impact factor: 2.1) DOI: 10.1002/bdd.519. PMID: 17009337.
Rawas-Qalaji MM, Simons ER, Simons KJ. Fast-Disintegrating Sublingual Tablets: Effect of Tablet Dimensions on Tablet Characteristics. Drug Dev Ind Pharm. 2007;33(5):523-530. (Times Cited: 5, Impact factor: 1.5) DOI: 10.1080/03639040600897150. PMID: 17520443.
Rawas-Qalaji MM, Simons ER, Simons KJ. Long-Term Stability of Epinephrine Dispensed in Unsealed Syringes for the First-Aid Treatment of Anaphylaxis. Ann Allergy Asthma Immunol . 2009;102(6):500-503. (Times Cited: 10, Impact factor: 2.8) PMID: 19558009.
Rachid OM, Simons FER, Rawas-Qalaji MM, Simons KJ. An Electronic Tongue: Evaluation of the Masking Efficacy of Sweetening and/or Flavoring Agents on the Bitter Taste of Epinephrine. AAPS PhamSciTech. 2010 Jun;11(2):550-7. (Times Cited: 9, Impact factor: 1.4) DOI: 10.1208/s12249-010-9402-3. PMCID: PMC2902344.
Rachid OM, Rawas-Qalaji MM, Simons FER, Simons KJ. Dissolution Testing of Sublingual Tablets: A Novel In Vitro Method. AAPS PhamSciTech. 2011 Jun;12(2):544-52 . (Times Cited: 2, Impact factor: 1.4) DOI: 10.1208/s12249-011-9615-0. PMCID: PMC3134647.
Rawas-Qalaji MM, Williams C. Advances in Ocular Drug Delivery. Curr Eye Res. 2012: 37(5), 345–356. (Times Cited: 0, Impact factor:1.5) DOI: 10.3109/02713683.2011.652286. PMID: 22510004.
Rachid OM, Rawas-Qalaji MM, Simons FER, Simons KJ. Rapidly-disintegrating sublingual tablets of epinephrine: role of non-medicinal ingredients in formulation development. Eur J Pharm Biopharm. 2012 Jun 7 (Epub ahead of print). (Times Cited: 0, Impact factor:4.3) DOI: 10.1016/j.ejpb.2012.05.020. PMID: 22683694.
Rachid OM, Rawas-Qalaji MM, Simons FER, Simons KJ. Epinephrine (Adrenaline) Absorption from New-Generation, Taste-Masked Sublingual Tablets: A Preclinical Study. Accepted for publication in J Allergy Clin Immunol. 2012 (Impact factor: 11)

Presentations and Peer-Reviewed Abstracts

Rawas-Qalaji MM. The Role of b-Blockers in Heart Failure. Roche Symposium on Advances in the Management of Cardiovascular Diseases, Singapore, 1999
Simons KJ, Rawas-Qalaji MM, Chan ES, Simons ER. Stability of Epinephrine in Pre-Loaded Syringes Located in Pediatric Allergy Clinics for the Prompt Emergency Treatment of Anaphylaxis. AAPSJ 2003; 5(S1): 002784; Salt Lake City, UT (Oct 26-30, 2003)
Rawas-Qalaji MM, Gu X, Simons ER, Simons KJ. Formulation of Fast-Disintegrating Sublingual Epinephrine Tablets for the Fist-Aid Treatment of Anaphylaxis Away from Health Care Facilities.AAPSJ 2004; 6(S1): 001340 - Baltimore, MD (Nov 7-10, 2004)
Rawas-Qalaji MM, Simons ER, Simons KJ. Evaluation of the Effect of Changing Tablet Dimensions on the Characteristics of Fast-Disintegrating Sublingual Epinephrine Tablets for the Fist-Aid Treatment of Anaphylaxis Away from Health Care Facilities. AAPSJ 2004; 6(S1): 001328 - Baltimore, MD (Nov 7-10, 2004)
Rawas-Qalaji MM, Simons ER, Simons KJ. Stability of Epinephrine in Buffers and Human Saliva at 37 °C.AAPSJ 2004; 6(S1): 001313 - Baltimore, MD (Nov 7-10, 2004)
Rawas-Qalaji MM, Simons ER, Simons KJ. Pre-Loaded Epinephrine Syringes Stored Under Light in Dry or Humid Conditions at 38 °C for 5 Days are Stable for Emergency Treatment of Anaphylaxis. AAPSJ 2004; 6(S1): 001287 - Baltimore, MD (Nov 7-10, 2004)
Alessi-Severini S, Rawas-Qalaji MM, Racher A, Collins D, Kozyrskyj A. Prescribing Trends for Celecoxib (Celebrex®) in the Province of Manitoba: Influence of Published Clinical Evidence and Provincial Reimbursement Status.AAPSJ 2004; 6(S1): 002927 - Baltimore, MD (Nov 7-10, 2004)
Rawas-Qalaji MM, Simons ER, Simons KJ. Fast-Disintegrating Sublingual Epinephrine Tablets: Effect of Drug and Tablet Dimensions on Tablet Characteristics. AAPSJ 2005; 7(S2): 001041 - Nashville, TN (Nov 6-10, 2005)
Rawas-Qalaji MM, Simons ER, Simons KJ. Fast-Disintegrating Sublingual Epinephrine Tablets: Long Term Stability Study. AAPSJ 2005; 7(S2): 001051 - Nashville, TN (Nov 6-10, 2005)
Rawas-Qalaji MM, Simons ER, Simons KJ. Stability of Epinephrine Over Five Months at Four Different Non-Optimal Storage Conditions. J Allergy Clin Immunol 2005; 115(2): S136-137 - San Antonio, TX (Mar 18-22, 2005)
Rawas-Qalaji MM, Simons ER, Simons KJ. Epinephrine for the Treatment of Anaphylaxis: Sublingual Epinephrine Tablet Versus EpiPen®.J Allergy Clin Immunol 2006; 117(2): S85 - Miami Beach, FL (Mar 3-7, 2006)
Rawas-Qalaji MM. Epinephrine for the Treatment of Anaphylaxis: Sublingual Epinephrine Tablet Versus EpiPen®. Podium presentation during Allergy session in the American Academy of Allergy Asthma and Immunology Annual Meeting in Miami Beach, Florida (Mar 3-7, 2006)
Rawas-Qalaji MM, Simons ER, Simons KJ. Epinephrine for the Treatment of Anaphylaxis: Do all Sublingual Epinephrine Tablet Formulations with Similar In Vitro Characteristics have the Same Bioavailability? AAPSJ 2006; 8(S2): 001280 - San Antonio, TX (Oct 29-Nov 2, 2006)
Rawas-Qalaji MM, Simons ER, Simons KJ. Fast-Disintegrating Sublingual Epinephrine Tablets: High Temperature Stability Study. J Allergy Clin Immunol 2007; 119(1);S32-33 - San Diego, CA (Feb 23-27, 2007)
Rachid OM, Rawas-Qalaji MM, Simons FER, Simons KJ. Novel Epinephrine Sublingual Tablets: Does the Grade of the Microcrystalline Cellulose Diluent Affect the Dissolution Rate? AAPSJ 2007; 9(S2): 002341 - San Diego, CA (Nov 10-15, 2007)
Rachid OM, Rawas-Qalaji MM, Simons FER, Simons KJ. The Effect of Non-Medicinal Ingredients on the Dissolution of Epinephrine from Novel Sublingual Tablets. AAPSJ 2007; 9(S2): 002285 - San Diego, CA (Nov 10-15, 2007)
Rawas-Qalaji MM. A Novel Approach for the Emergency Treatment of Anaphylaxis. School of Pharmacy-University of Waterloo, Ontario, Canada, June 2008
Rachid OM, Rawas-Qalaji MM, Simons FER, Simons KJ. Novel Dissolution Apparatus Designed to Evaluate Sublingual Tablets. AAPSJ 2008; 10(S2): 000737 - Atlanta, GA (Nov 16-20, 2008)
Rawas-Qalaji MM, Nieves E, Desai K, Stubblefield J, Rachid O, Simons KJ. In vitro Diffusion of Epinephrine Nanoparticles Using a Flow-Through Diffusion System. JPPS 2010; 13(3): 81-82s - Vancouver, Ca (Jun 2-5, 2010)
Rawas-Qalaji MM. A Novel Approach for the treatment of Anaphylaxis. Ebla Private University, Aleppo, Syria, June 2010
Rawas-Qalaji MM. A Novel Approach for the treatment of Anaphylaxis. Asia Pharmaceutical Industries, Aleppo, Syria, July 2010
Rachid OM, Rawas-Qalaji MM, Simons FER, Simons KJ. Epinephrine Autoinjectors for the First-Aid Treatment of Anaphylaxis: Epinephrine Contents Post-Expiry Date. AAPSJ 2010; 12(S2): T3045 - New Orleans, LA (Nov 14-18, 2010)
Simons KJ, Rachid OM, Rawas-Qalaji MM, Simons FER. Epinephrine autoinjectors for the first-aid treatment of anaphylaxis: Epinephrine dose ejected after 11-13 years in controlled storage conditions. J Allergy Clin Immunol 2011; 127(2) SUPPL. 1: AB244 - San Francisco, CA (Mar 18-22, 2011)
Rawas-Qalaji MM, Desai K, Rachid O, Simons FER, Simons KJ. Development of Epinephrine Nanoparticles Using Chitosan for the Treatment of Anaphylaxis. AAPSJ 2011; 13(S2): W4174 - Washington, D.C. (Oct 23-27, 2011)
Rachid O, Rawas-Qalaji MM, Simons FER, Simons KJ. Rapidly-Disintegrating Sublingual Tablets of Epinephrine: Effect of Various Excipients on Disintegration and Dissolution. AAPSJ 2011; 13(S2): T3074 - Washington, D.C. (Oct 23-27, 2011)
Rachid O, Rawas-Qalaji MM, Simons FER, Simons KJ. Outdated Epinephrine Autoinjectors: Integrity of the Delivery Systems/ Stability of the Contents. AAPSJ 2011; 13(S2): M1026 - Washington, D.C. (Oct 23-27, 2011)
Rawas-Qalaji MM. Fabrication of Epinephrine Nanoparticles: Success and Failures. Graduate Seminar, College of Pharmacy-Nova Southeastern University, November 2011
Rawas-Qalaji MM, Nieves E. Fabrication of Epinephrine Nanoparticles Using Microfluidizer Processor for the Treatment of Anaphylaxis. Presented at NanoFlorida 2011, The 4th Annual NanoScience Technology Symposium in Miami, FL (September 30-October 1, 2011)
Simons KJ, Rachid O, Rawas-Qalaji MM, Wein M, Simons FER, Outdated Epinephrine Autoinjectors: Ejection Volume Integrity and Epinephrine Content and Dose. J Allergy Clin Immunol 2012; 129(1) SUPPL. 1: AB180 - Orlando, FL (Mar 2-6, 2012)
Yoo D., Rawas-Qalaji MM. In Vitro Evaluation of Xylitol Release from Baby Tooth Wipes. American Academy of Pediatric Dentistry (AAPD) Annual Session, San Diego, CA (May 24-27, 2012)
Rawas-Qalaji MM. Development of Epinephrine Nanoparticles Using Chitosan for the Treatment of Anaphylaxis. Research Day, College of Pharmacy-Nova Southeastern University, February 10, 2012
Yoo D., Rawas-Qalaji MM. In Vitro Evaluation of Xylitol Release from Baby Tooth Wipes. Research Day, College of Dentistry- Nova Southeastern University, May 14, 2012
Rawas-Qalaji MM, Nieves E. Fabrication of Epinephrine Nanoparticles Using Microfluidizer Processor for the Treatment of Anaphylaxis. Presented at the Association of Pharmacists of PR Meeting, Fajardo, PR (Aug 23 - 25, 2012)
Rawas-Qalaji MM, Rachid OM, Simons ER, Simons KJ. Fast-disintegrating Sublingual Epinephrine Tablets: Long Term Stability Study. AAPSJ 2012;14(S2): M1381 - Chicago, IL (Oct 14-18)
Rawas-Qalaji MM, Mendez B, Daghistani N, Rachid OM, Simons ER, Simons KJ. Evaluation of the Development of Epinephrine Nanoparticles using Ionic Gelation Technique. AAPSJ 2012;14(S2): T3243 - Chicago, IL (Oct 14-18)
Rachid O, Rawas-Qalaji MM, Simons FER, Simons KJ. New-Generation, Fast-Disintegrating Taste-Masked Epinephrine Sublingual Tablets: Preclinical Study. AAPSJ 2012;14(S2): M1291 - Chicago, IL (Oct 14-18)
Simons FER, Rachid O, Rawas-Qalaji MM, Simons KJ. New-Generation, Fast-Disintegrating Taste-Masked Epinephrine Sublingual Tablets: Preclinical Study. Collegium Internationale Allergologicum (CIA), Jeju Island, South Korea (Oct 16-19, 2012)

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