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Preclinical testing—Understanding

the basics first- The high costs of drug development (for both successful and unsuccessful candidates) results in exorbitant drug prices, leading to high healthcare expenditure. The only solution to reduce this burden is open communication between all science streams involved during the complete cycle, better alignment on “regulatory requirement” and “right experimental design,” along with transparency in sharing result and interpretation. This helps to reduce costs associated with drug development at each milestone, including the preclinical stage. It is clear that preclinical is a turning point for any drug, and involves millions of dollars. Selection of optimal experimental design, study protocol, assay, cell lines, and animal model with significant translation value have a tremendous impact on the completion of the preclinical phase with desired results. A significant amount of research is needed in generating sophisticated preclinical models to understand and evaluate the effects of disease-related factors, cellular microenvironments, and therapy-related (drug + device) parameters. Although 3D bioprinting, in silico are showing some promise, but still the question is whether these techniques are reducing— long experiments—to get better results or they are just generating more information in the pool of existing data. Databases can certainly help, but questions about data protection, safety, company policy, and openness to share all information remain unanswered. Importantly, outsourcing preclinical studies to Contract Research Organizations (CROs) can support companies and speed up preclinical development to a significant extent. Optimal, cost-effective, and timely collaborative research is the way forward to reduce health expenditure.

https://doi.org/10.1016/B978-0-12-821222-6.00002-6

Large-scale manufacturing of nanoparticles—An industrial outlook

Nanosuspensions and lipid nanoparticles are very promising drug delivery systems for overcoming drug-related challenges, and to develop better therapeutic systems for patients. Both systems have a wide application in biomedicine as well as in other fields of science. This chapter is a first compilation where only large-scale manufacturing as per industry standard for both drug delivery systems has been discussed. It is critical and important to control formulation and process-related variables to produce nanoformulations of desired quality. Timely communication with regulatory bodies, equipment suppliers, and excipient suppliers is beneficial to understand the impact of changed parameters on the quality of a product. Similarly, it is equally important to break the silos within an organization and to foster collaborations between different experts, especially formulation scientists, engineers, regulatory scientists, analysts, and packaging experts. This will speed up the process of nanoparticles formulation and process development. This chapter guides scientists, engineers, and other experts on the industrial outlook of nanoparticle production, requirements, and challenges

https://doi.org/10.1016/B978-0-12-821222-6.00004-X

Experimental evaluation of icodextrin delivery as pressurized aerosol (PIPAC): Antiadhesive and cytotoxic effects

Icodextrin (IDX) is an antiadhesive polymer that can be used as a carrier solution for intraperitoneal (IP) delivery of chemotherapeutic drugs. We examined the sprayability of IDX, the aerosol characteristics, the stability of the molecule after aerosolization, the effects of IDX on the adhesion of MKN45 human gastric cancer cells, the synergistic effect of aerosolized IDX with Cisplatin and Doxorubicin, and the chemical stability of IDX, Cisplatin, and Doxorubicin in combination.

https://doi.org/10.1016/j.ejso.2021.02.012

Charged curcumin nanoparticles for aerosolization

Positively charged CUR-PLGA-NPs increased depth of tissue penetration by 81.5% and tissue concentration by 80%. Electrostatic precipitation further improved the uptake of positively charged CUR-PLGA-NPs by 41.8%. The combination of positive charge and electrostatic precipitation have significant potential to improve tissue uptake of nanoparticles during intraperitoneal chemotherapy.

Coenzyme Q10 oral bioavailability: effect of formulation type

Coenzyme Q10 (CoQ10) is a promising candidate in the pharmaceutical and nutraceutical field. However, it has a poor bioavailability due to its very low aqueous solubility and high molecular weight. The purpose of this review is to discuss the different types of CoQ10 drug delivery systems (DDS) ranging from the simple oily dispersions to the nanotechnology-oriented systems such as nanocrystals, self-nanoemulsified drug delivery systems, etc. to overcome the solubility issue.

Algal Nanosuspensions for Dermal and Oral Delivery

Marine bioproducts like algae have a lot of potential in food, cosmetic and nutraceutical industry. Formulation is key to all these markets. To extract the potential benefits of algae is very important especially the solubility issues of available sticky/powder extracts. Nanosuspension offers ease of production, simple formulation steps and enhanced formulation performance of nano algae suspension for dermal and oral use.