Oral drug delivery technologies form an important part of the pharmaceutical industry, and represent the largest share of the overall market.
A key challenge being faced by pharmaceutical companies today is how to actually deliver new drug compounds in a safe and efficacious manner. This is particularly true for potent drugs which show poor solubility characteristics. This can lead to dosage forms which are either inefficient, are possibly dangerous due to their ADME profiles or are outright impossible to deliver with currently available tools. If a drug has reached this stage in its development and fails, the cost and time impacts on the producer are understandably unacceptable.
One potential option opening up new avenues in drug formulation and delivery are Liposomes. Liposomes are microscopic (unilamellar or multilamellar) vesicles that are formed as a result of self-assembly of phospholipids in an aqueous media resulting in closed bilayered structures.
They offer several advantages over conventional dosage forms like enhanced solubility of poorly soluble drugs, improved safety and also modify the pharmacokinetics of the drug associated with lipid membrane or contained within its aqueous environment. There are various methods to prepare liposome based drug product. Each method has its own advantage and limitations. The critical parameters in development of liposomes are encapsulation of drug, controlling the size of vesicles, removal of free drug, maintaining the drug:lipid ratio, and improving the stability of developed liposome based formulations.
In this webinar we will focus on the basic concept of liposome, various methods to develop liposome formulation and its physicochemical characterization techniques. Additionally, the critical process parameters to develop a liposome based product and desired product quality attributes will be discussed.
Although many complex steps are involved in liposome based product development, its advantage over conventional drug products make it one of the most acceptable carrier systems for drug delivery especially for highly potent and toxic drugs. As a result many liposome based drug formulations are being investigated, and some of them have been approved for human use.
Vandana Sonavaria, Ph.D.,
Vice President, Pharma Mfg Services, Piramal
Vandana has a Ph.D with honors from Massachusetts College of Pharmacy, Boston, USA, with a specialization in Pharmaceutics and Industrial Pharmacy.
Twenty Years of Experience of Global Pharmaceutical Industry - 14 years in USA and 6 years in India.
Lead the department to the development of formulations for NCEs, Novel Drug Delivery Systems, Conventional Dosage Forms and custom development for contract orders.
Leadership, Innovation and Vision for product development establishing initiatives that optimized growth opportunities.
Formulation Development experience fo liposomal aand nanoformualtion injectable dosage forms, NCE molecules, controlled release dosage form, liquid, sterile products, lyophilized drugs, suspensions, emulsion & microspheres drug delivery systems.
In depth knowledge of cGMP and validation requirements.
- Liposome basic concept
- Manufacturing process of liposome drug products
- Characterization techniques for liposome
- Current status and future potential of liposome drug product
- R&D Heads/Managers
- Outsourcing/Procurement Heads
- Business Heads
