Meet BASF Pharma Solutions @ AAPS PharmSci 360
Oct 25, 2020
Nov 05, 2020Add to calendar
Presenter: Bijan Zakeri
The purpose of this study was to evaluate the performance of the surfactants Polyoxyl 15 Hydroxystearate (Kolliphor® HS 15) and Polyoxyl-35-castor oil (Kolliphor® ELP) in stabilizing proteins formulations. Surfactants are an essential component of biologics formulations, as they stabilize protein therapeutics such as monoclonal antibodies and fusion proteins against destabilizing interfacial and hydrophobic interactions. The current toolbox of surfactants used in approved biologics formulations is limited to polysorbate 80, polysorbate 20, and poloxamer 188, with polysorbate 80 being the most commonly used surfactant. However, it is well established that polysorbates suffer from degradation issues that can cause safety concerns and damage to the active pharmaceutical ingredients (APIs). Therefore, there is an unmet need within the biopharmaceutical industry for additional surfactants that can be used to stabilize biologics formulations for parenteral administration.
Presenter: Jiantao Zhang
Taste-masking has proven to be a useful technique to improve patient compliance of oral dosages having bitter actives, especially for pediatric and geriatric products. Kollicoat® Smartseal 100P, a spray dried powder of methyl methacrylate-diethylaminoethyl methacrylate copolymer is an excellent coating polymer for taste masking as it is insoluble in saliva (pH 6.8-7.2) and dissolves quickly in the stomach (pH < 5.5). Highly soluble drugs when being coated can generate high osmotic pressure, resulting in a high concentration gradient across the coating layer and accelerating the drug release. This causes challenges for taste masking of water-soluble actives. In this study, the purpose is to evaluate the taste masking effect of Kollicoat® Smartseal 100P by using Diphenhydramine HCl (DPH), a highly water-soluble drug with strong bitter taste the model drug.
Oct. 27th, 9am-10am EST
Presenters: Narasimha Murthy, Norman Richardson
Moderator: Benjamin Goodyear
Previous in vitro studies with model membranes (i.e. Strat-M®), porcine skin and human skin suggest that cocoyl caprylocaprate, isopropyl myristate and octyldodecanol might be able to enhance the penetration of some common topical drugs, spanning a wide range of Log P values . To validate these observations, in vitro permeation studies through human skin were conducted with topical semi-solid creams containing cocoyl caprylocaprate (Kollicream® 3C), isopropyl myristate (Kollicream® IPM), octyldodecanol (Kollicream® OD), and/ or mineral oil. Each of these excipients was formulated into common cream bases which contained three different topical analgesic drugs, Ketoprofen (Log P = 3.1), Ibuprofen (Log P = 3.97) or Diclofenac Sodium (Log P = 04.51). Critical Quality Attributes (CQAs) such as pH, emulsion globule size, API partitioning, etc. were measured for all of the creams. This presentation will report the effect of the different lipid-based excipients (and mineral oil) on the skin permeation of each of the three APIs and compare with the CQAs to better understand their mechanism of penetration enhancement.
Nov. 5th 9am – 11am EST
Presenters: Ferdinand Brandl, Thorsten Cech, Krizia Karry, Suresh Bandari
Moderator: Sandip Tiwari
Development of oral solid dosage forms presents numerous challenges to formulators. These range from development studies to achieve startup formulation, speed and simplicity in process design, scale-up, and cost considerations. In this session we will present a digital tool for predicting a startup formulation along with recommendations for optimal drug-excipient combinations. Approaches to taste masking solutions in oral solid dosage forms using novel film forming polymer will be discussed. Challenges and opportunities in the development of oral controlled release formulations using hot melt extrusion 3D printing technology will also be discussed. Contributions from both Industry and Academia will be structured in four targeted presentations followed by Q&A sessions.