Open to all registered attendees on a complimentary basis, these forums offer in-depth coverage of technologies and services hosted by the presenting companies.
Meeting the Formulation Challenges of Bitter Tasting Drugs
Nigel Langley - Director Technical Service and Scientific Affairs, Pharma Solutions - North America
Jiantao Zhang - Technical Service Manager, Pharma Solutions - North America
Effective taste-masking of bitter APIs, especially for pediatric and geriatric drug products, is a very important challenge in the development of pharmaceutical dosage forms. This presentation will provide case-studies as examples of liquid dosage taste-masking using Kolliphor® RH40 and Kolliphor P188/407. In the case of taste-masking for solid oral dosage forms, the utility of BASF’s coating polymer excipient; Kollicoat® SR30D will be described. Lastly, the functional benefits and application of Kollicoat® Smartseal, a novel excipient that has been designed specifically for taste-masking, will be highlighted.
Single Particle Zeta Potential Characterization of Biological Nanoparticles using Tunable Resistive Pulse Sensing (TRPS)
Anoop K. Pal - Chief Scientist - Americas Region
Dimitri Aubert - Global Sales Director
Development, performance, and regulatory authorization of nanotechnology-based therapeutics are critically dependent on their physiological behaviors which in-turn relies on accurate, high-resolution nanoparticle characterization. Currently, several particle characterization techniques (such as TRPS, DLS/PALS, TEM, AFM, NTA, flow cytometry, etc.) exist, of which only Tunable Resistive Pulse Sensing (TRPS) provides simultaneous in-suspension information about particle size and zeta potential on particle-by-particle basis. The high resolution single particle size and zeta potential characterization provides a better understanding of variations among formulations enabling the analysis of a wide spectrum of nanoparticles and their mixtures. Thus, impacting nanomedicine development and their regulatory approval.
Designing Patient Friendly Dosage Forms to Target the Unique Therapeutic Needs of the ever-increasing Geriatric – “Silver Tsunami” - Patient Population
Presented by: Don Barbieri, Technical Development Manager – North America, SPI Pharma
As noted by Peter Scholes in a recent Pharmaceutical Technology Volume 2018 Supplement, “the so-called “silver tsunami” is poised to become one of the most meaningful social transformations of the 21st century.” *
With this concept in mind, SPI Pharma’s Technology Forum presentation is intended to initiate active discussion on developing dosage forms that are designed to meet the specialized needs of geriatric patient populations with a focus on improving patient therapeutic outcomes. If patients take their medications as prescribed, compliance increases with an associated increase in therapeutic success. Positive therapeutic outcomes can be accomplished through different approaches. One such approach is to develop Patient Friendly Dosage Forms. These products have good palatability, are convenient and easy for people to take, and improve the experience of taking and/or administering medication especially for those patients with dysphagia or other swallowing problems.
Patient Friendly Dosage Forms include, Orally Disintegrating Tablets (ODTs), soft gelatin capsules, Orally Dispersible Powders (ODP), chewable/meltable tablets, among others, and
offer scientists the opportunity to creatively develop extended and/or immediate release products in a wide range of size, shapes and flavors.
Such creativity will allow formulators to proactively address the specific dosing needs of the pending “silver tsunami” wave and the ever-increasing needs of diverse patient populations.
* Removing the Bitter Taste from Drug Development by Peter Scholes, Pharmaceutical Technology Volume 2018 Supplement, Issue 2, pg s6-s10
Presented By: Ketaki Patwardhan, Ph.D., Principal Scientist, Products & Formulations, Evonik Health Care
Solid dispersion technologies like spray drying and hot melt extrusion convert poorly soluble crystalline actives into amorphous forms within a polymeric matrix. To stabilize the amorphous form of actives with high states of energy, strong interaction with the polymeric matrix and high glass-transition are important polymer attributes. EUDRAGIT® polymers with inherent ionic and strong H-bonding interactions will be reviewed with comparison to other polymeric systems.
Light scattering addresses many key analytical challenges in drug nanoparticle R&D, including accurate size distributions, conformation, payload and formulation. We review light scattering fundamentals, then present examples illustrating how Wyatt's unique light scattering instrumentation facilitates rapid and effective development of controlled release vehicles including liposomes, VLPs, polymer-encapsulated nanoparticles and nanogels.
Characterizing Controlled Release Vehicles
Using multiple analytical techniques to better understand the properties of CRVs
Presented by: Matt McGann
From quantifying the encapsulation efficiency, to elucidating mechanisms of release, a multifaceted analytical approach to characterizing controlled release vehicles (CRVs) provides better understanding of their properties. In this forum Malvern Panalytical will introduce a range of techniques including DLS, NTA, XRD, GPC, and ITC and demonstrate how these data sets help improve product quality and understanding.
Presented by: Drug Delivery Experts CEO Christopher A. Rhodes, Ph.D.
Drug Delivery Experts (DDE) is a contract R&D drug delivery laboratory located in San Diego's emerging biotech sector that excels in integrating the right formulation, delivery system, and device to fit the therapeutic product need.
DDE was created to address gaps in the formulation and drug delivery technology landscape. While solving our client’s most challenging drug delivery issues, our experts leverage their experiences and backgrounds to develop new delivery technologies.
CEO Christopher A. Rhodes, Ph.D. will speak about what we do best in the areas of Sustained Release Gel Formulation, Peptide Salt Screening and Selection, and Injection Site Reaction Issues, as well as highlight Future Trends in Drug Delivery Technology.
The session is meant to be interactive with a few leading slides for each discussion, so that attendees will have the opportunity to interact and ask questions.
Presented By: Firouz Asgarzadeh, Ph.D., Director Formulation and Application Services, Products and Formulations, Evonik Health Care
Most proteins and peptides are BCS class III. To overcome their often-poor bioavailability, Evonik recently introduced a new modular platform technology for improving the bioavailability of peptides. The EUDRATEC® PEP technology allows treatment with an oral solid form, replacing unpleasant injections and therefore tremendously enhancing patient compliance.
Presented By: Dan Spisak
The concept of small volume dissolution arises from the need to analytically determine the rate of dissolution from low dose, generally high potency drugs. Novel drug delivery design has demanded more from typical official dissolution and drug release apparatus. To maintain quantitative levels of analyte during the dissolution test, a reduction in vessel volume accompanied by an alteration of compendial dissolution apparatus may be required. The need to develop small volume dissolution apparatus stems from the need to provide accurate, reliable data for decision making during drug development stages and assurance of quality when the formulation reached full-scale production and to maintain future assurance of product quality and stability. This forum will explore the use of USP apparatus and modifications to the standard USP apparatus designed to yield small volume dissolution methods with reliable results.
Strategies for the Formation and Coating of Multiparticulates for use in modified release products using the Conical Rotor Processor
Richard Sidwell, PhD, Sr. Director Product Development - Recro Gainesville
Ryan Crawford, Process Development Scientist – Freund Vector.
Long processing times are common in the manufacture of high potency, modified release beads. Using the Granurex©, a conical rotary system, spherical beads can be manufactured and coated in a fraction of the time required when compared to traditional processes.
In development of differentiated drug products, Pharmaceutical companies often outsource animal testing to preclinical CROs for establishing bioequivalence / superiority to the RLD. This presentation will address the strategies involving canine as a best animal model for development of differentiated drug product dosage forms.