Abstract
Crystal engineering technique has been widely explored in recent times to bring about changes in crystallinity which aids to achieve various goals such as solubility enhancement, stability and in vivo bioavailability without altering the chemical properties of the drug. Cocrystallisation is one of the crystal engineering approaches where the drug and an inert coformer are linked together by hydrogen bonding forming supramolecular homosynthon or heterosynthon using solvent-based or solvent-free techniques. Processing of active pharmaceutical ingredients with inert water-soluble coformers yields multicomponent crystalline cocrystals with high-performance characteristics and enhanced flow properties. Due to the emerging need of the industry for greener techniques, hot melt extrusion (HME), a continuous and solvent-free process is emerging as a field of interest in the mechanochemical synthesis of various pharmaceutical dosage forms such as solid dispersions, implants, ointments, and cocrystals. The current review emphasizes the role of HME as a cocrystallization technique for drugs to tailor-make their properties and ease of formulation. The distinct feature of HME is phase control during the process of cocrystallization. Furthermore, the selection of appropriate coformers with desirable water-solubility and stability features makes HME amenable to cocrystallization of versatile actives yielding suitable dosage forms. The application of process analytical technology further adds ease of monitoring during HME in cocrystallization approaches. Due to these salient features of HME, it can act as a prospective technique for cocrystallization of versatile drugs thus yielding dosage forms with desirable solubility and stability features.
Highlights
Combinatorial chemistry and high-throughput screening have paved a way for new drug candidates by which innumerable new molecules are generated
The pharmaceutical industry generally faces a lot of challenges in pharmaceutical processing of drugs having low solubility issues
This leads to increased investment in R and D and clinical trials and increases the time required for developing new drugs
Summary
Combinatorial chemistry and high-throughput screening have paved a way for new drug candidates by which innumerable new molecules are generated. If the excipients used in HME process exhibit required pharmaceutical properties and safety parameters, the excipients can aid to yield final products with desirable bioavailability and stability characteristics. The melting characteristics of excipients and polymers used and the binding properties during extrusion process play a key role in imparting desirable characteristics to extruded drug-excipient blends.
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