Pankaj Sharma

By Pankaj Sharma

In the novel dosage form development, quality is the key criterion in pharmaceutical industry. The quality by design tools used for development of the quality products with tight specification and rigid process. The specifications of statistical tools are essentially based upon critical process parameters (CPPs), critical material attributes (CMAs), and critical quality attributes (CQAs) for the development of quality products. The application of quality by design in pharmaceutical dosage form development is systematic, requiring multivariate experiments employing process analytical technology (PAT) and other experiments to recognize critical quality attributes depend upon risk assessments (RAs). The quality by design is a modern technique to stabilize the quality of pharmaceutical dosage form. The elements of quality by design such as process analytical techniques, risk assessment, and design of experiment support for assurance of the strategy control for every dosage form with a choice of regular monitoring and enhancement for a quality dosage form. This chapter represents the concepts and applications of the most common screening of designs/experiments, comparative experiments, response surface methodology, and regression analysis. The data collected from the dosage form designing during laboratory experiments, provide the substructure for pivotal or pilot scale development. Statistical tools help not only in understanding and identifying CMAs and CPPs in product designing, but also in comprehension of the role and relationship between these in attaining a target quality. Although, the implementation of statistical approaches in the development of dosage form is strongly recommended.

Part of the book: Smart Drug Delivery

By Pankaj Sharma, Vinay Jain and Mukul Tailang

Polymers have helped to develop drug carrier technologies by allowing for the regulated release of bioactive molecules in consistent dosages over extended periods of time, cyclic dosing, and adjustable delivery of both hydrophobic and hydrophilic medicines. Formulations are released in a coordinated and consistent fashion over long periods of time. Polymers going to act as just an inert carrier whereby a substance can be conjugated having significant advantages. For instance, the polymer enhances the pharmacodynamic and pharmacokinetic characteristics of biopharmaceuticals in a variety of ways, such as plasma half-life, reduces immunogenicity, increases biopharmaceutical consistency, enhances the solubilization of low-molecular-weight substances, and has the prospects for targeted delivery. Smart polymeric delivery systems, in instance, have been investigated as “smart” delivery methods capable of releasing encapsulated pharmaceuticals at the right time and place of activity with respect to certain physiological stimuli. The development of novel polymeric materials and cross-linkers that are more biocompatible and biodegradable would expand and improve present uses. Polymer sensitivity to a particular stimulus may be tuned within a limited range because of the diversity of polymer substrates and their sequential production. The methods through which polymer frameworks are formed in situ to construct implanted systems for continuous release of medicinal macromolecules are discussed in this chapter, as well as numerous applicability of enhanced drug delivery.

Part of the book: Drug Carriers