Shaukat Ali

.


 BASF
USA

Shaukat Ali, after a brief tenure at the University of Bridgeport had joined the industry and worked in drug discovery and formulation development. He has over 21 years of experience in the pharmaceutical industries including 11 years at BASF, where he supports solubilization, instant and modified release platforms, and APIs.  His areas of expertise include solid dispersions, liposome drug delivery, controlled release, transdermal, and film development technologies.
He is a member of the editorial advisory boards of, American Pharmaceutical reviews, Biopharma Asia, Contract Pharma, Drug Delivery & Development, International Journal of Pharmaceutical Investigation. He is also USP panel of experts for General Chapters-Physical Analysis.
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 holds an adjunct faculty at the College of Pharmacy of University of South Florida, Tampa. He has authored over 37 scientific articles and is co-inventor in 14 US patents.
 

Research Interest

Solid dispersions; Liposome drug delivery; Controlled release; Transdermal; Film development technologies.
links
 https://www.linkedin.com/in/shaukat-ali-57641b15

 

Summary

Profile:
9 ½ years of experience with BASF in Pharma Ingredients & Services, and about 10 years in Pharma industry in areas of drug discovery and formulations development- solid and liquid oral, parenteral and transdermal drug delivery technologies; expertise include (a) solubilization by solid dispersion technologies (hot melt extrusion and spray drying), and surfactant/lipid based emulsifying systems (SEDDS/SMEDDS) (b) Quick dissolving films (c) design of gastroretentive dosages, fluid bed granulation and controlled release and taste masking coatings (d) lyophilization of parenteral formulations of poorly soluble drugs (e) liposome drug delivery (f) regulatory and toxicology of excipients and drug substances (g) analytical method development and stability of dosages (h) process development and technology transfer for clinical manufacturing (g) product’s internal monographs, specifications, and CMC (i) managerial and entrepreneurship skills complemented with good writing and communication abilities.

Organizational/Editorial Board Members:
American Pharmaceutical Review
Biopharma Asia UK
Contract Pharma
Drug Development and Delivery
International Journal of Pharmaceutical Investigation
Pharmaceutical Technology-Sourcing and Management
USP Expert Committee for General Chapters-Physical Analysis

Publications:
25 scientific articles and inventor/co-inventor in 14 US patents.

Academic:
Assistant Professor, Chemistry, University of Bridgeport, Connecticut (1993-1994)
Adjunct Visiting Faculty, College of Pharmacy, University of South Florida, Tampa, FL

Experience

Technical Support Manager

BASF

March 2004 – Present (12 years 2 months)

Assoc. Director

Lavipharm

September 2003 – March 2004 (7 months)

Assistant Principal Scientist

The Liposome Company, Inc. (Subs. Elan Corp.)

August 1994 – June 2001 (6 years 11 months)

Education

Joan & Sanford I. Weill Medical College of Cornell University

Postdoc, Physical Biochemistry

1991 – 1992

University of Minnesota - Hormel Institute

Postdoc, Surface Chemistry and Physical Biochemistry

1989 – 1991

City University of New York

Doctor of Philosophy (PhD), Chemistry

1984 – 1989

Laurentian University/Université Laurentienne

MS, Chemistry

1982 – 1984

Aligarh Muslim University

MSc, Chemistry

1977 – 1979

 

Shaukat Ali has spent most of his professional life immersed in lipids. After obtaining a PhD from the City University of New York in lipid-chemistry and the post-doc from the University of Minnesota and Cornell University in the physical biochemistry of lipids, he joined The Liposome Company (Princeton, NJ), where he developed methods to reduce drug toxicity by formulation in liposomes. Now, as Technical Support Manager for Pharma Ingredients & Services at BASF, Ali promotes BASF’s range of solubilizers and polymers for drug formulation, including a selection of lipid-based drug delivery systems (LBDDSs). “The bioavailability challenge is enormous,” Ali says. “There is no one-size-fits-all approach, but it’s immensely satisfying to determine the best formulation for a given molecule.”

The insolubility solution

Water-insoluble drugs usually dissolve in non-aqueous solvents, such as ethanol, but will rapidly precipitate once that solution is introduced to an aqueous medium, such as which is found in the stomach. Oral delivery of these drugs, however, is not impossible. Ali says the key, is to add other components or solubilizers to the non-aqueous drug solution so when the solution is mixed with an aqueous medium, it emulsifies to form tiny droplets that contain the drug and protect it from exposure to water. Ideally, the droplets both prevent drug precipitation and are readily absorbed. The magic ingredients that promote emulsification are surfactants – molecules that have both hydrophobic and hydrophilic regions, providing them with the convenient ability to interact with both aqueous and non-aqueous media. “In practice, this means that the solution of drug dissolved in the non-aqueous solvent is distributed in the aqueous medium as a suspension of microdroplets – a microemulsion – each bound by a layer of surfactants in which the hydrophobic tails of the surfactant are oriented to the interior of the micelle, and the hydrophilic headgroups oriented to the exterior,” explains Ali.
Ali’s expertise lies in the precise choice of surfactants. Getting the lipid based surfactants right is crucial because all surfactants have different chemistries and every drug is unique. “It’s a case of matching the correct surfactant to a given drug in the context of that drug’s delivery requirements. The aim is to identify a surfactant which can not only emulsify the drug as outlined above, but also ensure that the drug remains encapsulated in the interior core during gastro-intestinal transit, ultimately getting efficiently absorbed,” says Ali.

Fat benefits

When it comes to micro-emulsion stability, Ali points out that drugs need to remain in solution for extended periods – perhaps 3-5 hours – as they move through the stomach to the absorptive region of the gut. A drug may seem perfectly stable in a given LBDDS at first, but if it starts precipitating after only 30 minutes then the formulation will need to be redesigned. Furthermore, given the number and range of pH changes to which the micro-emulsion droplets are exposed  as they move from stomach to intestine, it is essential the droplets remain stable over a broad pH range. Ali says, “The ideal surfactant should be non-ionic so it is resistant to pH changes.”
However, it is not just gastrointestinal pH fluctuations that can cause problems – what about all the digestive enzymes? If enzymes penetrate the micro-emulsion, they hydrolyze the surfactant fatty acid chains, breaking down the ester linkage between the hydrophilic and hydrophobic parts of the surfactant. Once that happens, the droplets rapidly break down, exposing their drug cargo to aqueous media, which results in drug precipitation. Resistance to digestion therefore is essential; and it too depends on the surfactant’s fatty acid composition of the micro-droplets. “The packing of fatty acid chains inside the microemulsion is critical to the stability of the LBDDS formulation,” says Ali. “One solution is to use an emulsifying agent (such as BASF’s polyoxyl 40 hydrogenated castor oil (Kolliphor® RH40) that has a long, saturated C18 fatty acid chain that goes deep into the droplet core.  These features will reinforce the micro-emulsion surface by making it more tightly packed and promoting lateral interactions between fatty acid chains like those found in lipid-cholesterol natural membrane.” Such features keep out digestive enzymes, protecting surfactant molecules from ester cleavage, whereas surfactants with short and unsaturated fatty acid chains may provide looser packing and less effective enzyme exclusion, making them less digestion-resistant.
To promote good drug absorption, emulsion droplet size is critical. Droplet size is a function of emulsification rate, which in turn is, again, dependent on the amount of surfactants in the formulation. Ali says that BASF’s surfactants routinely provide droplets of 20-150 nm, depending on the precise surfactant and formulation composition. “At that size, they just disappear in an aqueous medium –the solution is completely clear. Nanometre-sized droplets get absorbed very efficiently, which is always a benefit in drug delivery,” he says.

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