Articles in this Issue
Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
A number of patents are issued every month to many pharmaceutical companies. The purpose of this column is to highlight and summarize key patents issued from October to November 2014 by the US Patent Office (www.uspto.gov.)
Masakazu Tsuchiya, PhD
Low Endotoxin Recovery (LER) was first presented by Dr. Joseph Chen in April 2013. A masking effect of endotoxin was observed with a matrix containing a chelating agent and a detergent, and the endotoxin potency was not successfully recovered by dilution or magnesium replacement, the usual way to overcome the inhibition caused by chelation.
Dawn McIver
Environmental monitoring (EM) is a crucial component of the microbial testing required in pharmaceutical manufacturing. The purpose of EM is to assess the microbiological control of the environment by trending
the number and type of organisms recovered over time. Conventional methods for EM which are used widely include contact plates for surface and airborne viable monitoring.
Ali Cinar, PhD, Elif Seyma Bayrak, Kamuran Turksoy
The potential impact of simulation-based engineering science on advances in science and technology and current challenges are documented in a recent NSF report. The challenges include difficulties inherent in multi-scale modeling, the design and implementation
of dynamic data-driven application systems, the improvement of methods to quantify uncertainty and model validation, and better integration of data-intensive computing, visualization, and simulation.
Robert Heintz
An important area for the advancement of pharmaceuticals is in product formulation development. The active pharmaceutical ingredient (API) delivery method can be as important as the drug itself. Hot melt extrusion (HME) is a method that has been used quite extensively in the plastics industry to produce a wide assortment of plastic products in a variety of forms. HME applied to the production of pharmaceutical formulations is a relatively new method being developed as an
attractive alternative to traditional processing methods for producing products such as tablets, granules, pellets, and even transdermal films.
Syed Salman Lateef, PhD, Vinayak AK, Michael W. Dong, Ph.D.,, Christine C. Gu, Ph.D
After the manufacture of a given drug, a cleaning verification (CV) analysis must be performed to demonstrate the “cleanliness” of the production train (vessels and processing equipment) to confirm
that the active pharmaceutical ingredient (API) has been adequately removed to pre-established acceptance limits (maximum allowable carryover) before a new pharmaceutical can be made in the same equipment.
John B. Cannon, Ph.D.
Lipid formulations, while gaining increasing importance in parenteral and oral drug delivery, are also important in transdermal and topical
drug delivery. Examples and mechanisms by which lipids enhance the transport of drugs transdermally (through the skin) and topically (into the skin) will be discussed. Lipid formulations can form structures
such as micelles, reverse micelles, emulsions, microemulsions, and liposomes that can aid delivery into and through the skin. A case study will be presented of a topical immunosuppressant investigated for the treatment of atopic dermatitis and psoriasis. A lipid-based polymeric ointment formulation gave superior skin uptake in vitro and in an in vivo swine efficacy model.
Stephen Ball
The trend in the biopharmaceutical industry is for clinical products to be available as high concentration formulations, allowing for administration to the patient at low dose and frequency while also satisfying a shelf-life of up to 2 years. This requires the biological to be present at high concentration within a formulation that is both low in viscosity and not prone to aggregation. Developing such formulations
can be challenging, and there is considerable emphasis today on understanding the relationships and processes that contribute to successful high concentration formulations, and the mechanisms
leading to aggregation.