Quality by Design (QbD)

Abstract The porosity of a pharmaceutical tablet influences liquid transport, disintegration and dissolution, rendering its monitoring and control crucial for quality by design. Optical porosimetry, a non-destructive process analytical technology (PAT), combines gas in scattering media absorption…
Read More...

Abstract Ivermectin (IVM) is a widely used antiparasitic agent and has been repurposed for the treatment of COVID-19. However, its poor water solubility and low bioavailability present significant challenges, often requiring large doses for therapeutic effectiveness. This poses a burden on…
Read More...

Abstract The main purpose of this study was to design and develop a solid self-nanoemulsifying drug delivery system (S-SNEDDS) for the oral administration of benidipine (BD) and telmisartan (TEL) using the adsorption method with eucalyptus oil, Transcutol P, and Kolliphor EL via the Box–Behnken…
Read More...

Abstract There is a significant deficiency of suitable pediatric medications, attributed to limited market, trial complexities, and strict regulatory requirements. Ensuring appropriate dosing and medication acceptance in this population requires careful consideration of age, weight, and…
Read More...

Abstract The current study presents a comprehensive pharmaceutical engineering approach to developing an advanced transdermal drug delivery system for addressing skin hyperpigmentation through innovative nanocomposite gel formulation. Utilizing a systematic Quality-by-Design (QbD) methodology with…
Read More...

This paper covers a brief overview of the steps for pharmaceutical product development under the quality by design (QbD) framework; introduces design of experiments (DoE) applied to formulation of tablets and gives an example of how to design piroxicam amorphous solid dispersions (ASD) tablets using…
Read More...

Abstract Ternary co-amorphous systems, comprising a drug, a low molecular weight co-former, and a polymer, are a promising approach to address the solubility and stability challenges of poorly water-soluble drugs. However, it is unclear how the addition of a third component influences the stability…
Read More...

Introduction Self-emulsifying drug delivery systems (SEDDS) have emerged as a promising approach for enhancing the oral bioavailability of challenging therapeutic compounds, particularly biopharmaceuticals like proteins and peptides. A study published in “Pharmaceutics” journal showcases an…
Read More...

Purpose Understanding batch-to-batch variation of excipients and correlating this to process performance is a key concept of Quality-by-Design for pharmaceutical product development. In this study, the effect of batch-to-batch variation in material properties of milled lactose monohydrate on…
Read More...

Itraconazole (ITZ), a BCS Class II drug exhibiting low solubility (1-4 ng/ mL in water) requires formulation enhancement to achieve enhanced bioavailability. To tackle this problem amorphous solid dispersions (ASDS) of ITZ in a polymer matrix (Kollidon® VA64) were produced using the Hot Melt…
Read More...