New paper added on MySTYL’One.

The formulation development of amorphous solid dispersions (ASDs) towards a patient-friendly oral solid dosage form is proving to be still challenging. To increase patient’s compliance orodispersible tablets (ODTs) can be seen as promising alternative. Two different ASDs were prepared via hot melt extrusion (HME), using PVPVA as polymer for ritonavir (RTV) and HPMCAS for lopinavir (LPV). The extrudates were also milled, sieved, and blended.

Conclusions

• The selected ASD particle size was pointed out to be a key parameter for a fast disintegration and high mechanical strength.
• In terms of PVPVA based ASDs, larger particle sizes > 500 µm enabled a rapid disintegration even under 30 s for 50 % ASD loaded ODTs
• The use of smaller particles went along with significant higher disintegration times
• The influence of the CPE was immense for PVPVA based ASDs
•  In contrast for HPMCAS based ASDs the selection of smaller particle sizes 180–500 µm was beneficial for overcoming the poor compressibility of the ASD matrix polymer

With the ever-growing pressure to get new therapies to patients faster, predictive modeling and simulation tools are increasingly recognized as critical enabling technologies for accelerating drug product development. In the development of oral solid dosage forms, predictive modeling and simulation tools of the manufacturing processes can enhance process understanding, save on API supply, improve product quality, and reduce or eliminate many of the bottlenecks associated with empirical methods.

Each active pharmaceutical ingredient (API) has its own set of unique physical and chemical properties that can affect the success of product formulations and manufacturing routes. On account of this, the manufacturing process for solid dosage forms need to be thoroughly understood. Determining robust formulations and processes for a given compound requires a deep understanding of material science and powder behavior.

The present works demonstrated from a study to predict capping on biconvex tablets from a wide range of products (18 formulations, 8 of which presenting capping), using the properties characterized on defect-free flat-faced tablets (tensile strength, solid fraction, elastic recovery, etc.). The study is available in the PAPERS section.

Find others papers here and learn about

• Use of impulse excitation technique for the characterization of the elastic anisotropy of pharmaceutical tablets
  
• Enabling the direct compression of metformin hydrochloride through QESD crystallization
  
• Role of Precompression in the Mitigation of Capping: A Case Study