Pharmaceutical Product Characterization and Manufacturability of Surfactant-Enriched Oil Marbles with Abiraterone Acetate.

The present study investigates the physicochemical properties and stability of a novel lipid-based formulation-surfactant-enriched oil marbles containing abiraterone acetate. While the biopharmaceutical performance of this formulation has been reported recently, this study aims to fill the gap between a promising in vivo performance and industrial applicability. A series of techniques were employed to assess the solid-state characteristics of oil marble cores along with their physicochemical properties upon stability testing. The chemical stability of abiraterone acetate in the formulation was also investigated. The core of the formulation was found to be stable both physically and chemically over 12 months of storage. The in vitro performance of stressed samples was evaluated using a dissolution experiment. The formulation has successfully self-emulsified upon incubation in bio-relevant media, resulting in a fast and complete API release. An important issue connected with the excipient used as a covering material of oil marbles has been identified. The seemingly insignificant water sorption caused agglomeration of the oil marbles and consequently compromised the dissolution rate in some of the stressed samples. Replacing HPMC with lactose as a covering material resulted in more favorable properties upon storage. Overall, it has been shown that oil marbles are an industrially applicable concept of the solidified lipid-based formulation.

Vibrational spectroscopic analysis of critical micelle concentration in sodium decanoate solutions.

The presented study is devoted to the investigation of the micellization-induced liquid-liquid fluctuations in sodium decanoate (NaD) aqueous solutions, based on the vibrational spectroscopic study of NaD and the determination of critical micelle concentration (CMC) of this system. At the same time, we focused on monitoring the effect of the addition of decanol to this system and changing its basic parameters from the point of view of CMC. CMC is an important parameter from a practical point of view and a characteristic feature of each micelle-forming compound. Upon analyzing the spectroscopic data we focus our attention mainly on the intensity and band position variations of both the symmetrical and antisymmetrical vibrational modes of CH2 groups situated in the high-frequency part of the spectrum. The study used normal (non-enhanced) Raman spectroscopy with excitation wavelength 785 nm, surface-enhanced Raman spectroscopy (SERS) on large-scaled gold-coated SERS-active substrates and infrared spectral measurements. The results of spectroscopic measurements were supported by tensiometry and potentiometry.