Pacira BioSciences. has filed a patent for a process to prepare bupivacaine multivesicular liposomes (MVLs) using a commercial manufacturing process. The process involves several steps, including emulsion formation, solvent removal, microfiltration, and diafiltration. The final composition has a volume of 100 L to 250 L and a bupivacaine concentration of 11.3 mg/mL to 17.0 mg/mL. The composition is stored under aseptic conditions and has a low erucic acid concentration after six months of storage. Additionally, the composition contains lysine encapsulated in the MVLs. GlobalData’s report on Pacira BioSciences gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Pacira BioSciences, Cancer treatment biomarkers was a key innovation area identified from patents. Pacira BioSciences's grant share as of September 2023 was 52%. Grant share is based on the ratio of number of grants to total number of patents.

The patent filed is for a process to prepare bupivacaine liposomes

Source: United States Patent and Trademark Office (USPTO). Credit: Pacira BioSciences Inc

A recently filed patent (Publication Number: US20230301916A1) describes a composition of bupivacaine encapsulated multivesicular liposomes (MVLs) and a process for preparing it. The process involves several steps, including mixing aqueous solutions with a volatile water-immiscible solvent solution, removing the solvent, and exchanging the supernatant with a saline solution. The resulting composition has a volume of about 100 L to 250 L and a bupivacaine concentration of about 11.3 mg/mL to 17.0 mg/mL. All steps are carried out under aseptic conditions to ensure product safety. The composition also contains lysine encapsulated in the internal aqueous chambers of the MVLs, with a concentration of about 0.03 mg/mL.

The patent also includes additional claims regarding the composition and its method of use. These claims specify various parameters and conditions, such as the pH of the composition after storage, the mixing speeds and times during the preparation process, the concentration of bupivacaine and lysine, and the presence of other components like cholesterol and neutral lipids. The patent further describes the potential applications of the composition, including providing local or regional analgesia to patients in need. The administration can be done via local infiltration to a surgical site or through nerve blocks for postsurgical pain management. The composition can be provided in single-dose volumes of 10 mL or 20 mL.

Overall, this patent describes a novel composition of bupivacaine encapsulated MVLs and a detailed process for its preparation. The composition offers potential advantages in terms of lysine encapsulation, pH stability, and reduced H+ concentration compared to existing commercial products. The patent also highlights the method of administration and the potential applications of the composition in providing effective pain relief for surgical patients.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies