29. April 2017

Abstract Thoughtfully designed early clinical formulations not only meet the needs of the study at hand and inform the development of the commercial product, but can influence the direction of the clinical program as well as provide further guidance to potential backups still in exploratory stages. This chapter focuses on the various types of early clinical formulations, why they are developed, and how the preclinical formulation space helps to guide initial clinical formulation selection....

29. April 2017

The aim of this study was to develop oral lyophilisates with improved meloxicam (MEL) dissolution, optimizing each step of the preparation by design of experiments. First, meloxicam nanosuspensions were prepared by high-pressure homogenization (HPH), using PVP, Poloxamer or PEG as stabilizers and were subjected to freeze-drying using mannitol as cryoprotectant.

28. April 2017

The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.

28. April 2017

Chemical Exchange Saturation Transfer (CEST) approach is a novel tool within magnetic resonance imaging (MRI) that allows visualization of molecules possessing exchangeable protons with water

28. April 2017

Ceftriaxone; Non-parenteral administration; Stability; Compatibility; Pharmaceutical process simulation; Near infrared (NIR) spectroscopy; X-ray diffraction (XRD); excipient

28. April 2017

VLV, hypromellose, Tablet coating Box–Behnken design, Toughness index ,

28. April 2017

Paediatric formulation; Flexible formulation; Orodipersible formulation; Excipient; Disintegration

26. April 2017

A colon-specific capsule with alginate beads containing a self-microemulsifying drug delivery system (SMEDDS) was developed and evaluated. The SMEDDS technique was used to improve the solubility of curcumin (Cur). After encapsulating the Cur-loaded SMEDDS, the alginate beads were placed inside an impermeable capsule body. A konjac glucomannan/lactose/hydroxypropyl methylcellulose (KG/Lac/HPMC) plug tablet was then prepared and placed in the mouth of the capsule. The capsule demonstrated a...

26. April 2017

Abstract Content uniformity of low dose blends with fine active pharmaceutical ingredients (API) is adversely impacted due to API agglomeration caused by high powder cohesion. Dry coating using high-intensity vibratory mixing is employed to reduce API cohesion and granular Bond number as well as agglomeration as predicted by contact models, hence improve blend content uniformity (CU). Micronized acetaminophen (mAPAP) (~ 10 μm), a model API, was dry coated with nano-silica R972P (20 nm), and...

26. April 2017

Abstract The aim was to develop immediate-release carbamazepine tablets consisting of self-emulsified drug delivery system (SEDDS) by using the melt granulation technique, application of Quality by design. The first set of screening experiments investigated the influence of six parameters (meltable binder type; amounts of meltable binder, carbamazepine and crospovidone; carrier type, and compression force) on carbamazepine release rate from tablets, using fractional factorial experimental...