Merck Sharp + Dohme Corp.

Merck Sharp + Dohme B.v.

Luke R Schenck

Aaron S Cote

Sachin Mittal

Irina Kazakevich

Himanshu Bhattacharjee

Peter Bakker

Nazia Khawaja

David J Lamberto

David J Goldfarb

Joseph L Kukura, Ii

Francisco J Guzman

Amitava Mitra

Athanas Koynov

Donna Carroll

A process for preparing and isolating pharmaceutical active ingredient particles having a particle size of between about 0.1 and 30 microns, wherein a slurry comprising the active ingredient and one or more pharmaceutically acceptable excipients is fed into a thin film evaporator under suitable conditions for less than 10 minutes sufficient to generate solid matrix particles comprising active ingredient and one or more excipients, wherein the particles have less than 5% residual solvent.

Process for preparing pharmaceutical compositions

The instant invention provides pharmaceutical formulations for a long acting injectable drug product comprising a suspension of doravirine for parenteral administration via intramuscular or subcutaneous routes. The drug product can be used for the treatment or prophylaxis of infection by HIV or for the treatment, prophylaxis, or delay in the onset of AIDS (acquired immunodeficiency syndrome) or ARC (AIDS related complex).

Formulation for parenteral administration

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Yardley, PA, United States of America

Luke R Schenck