Recent Publications

The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference

Date:

5/27/25

Citation:

Schug B, Beuerle G, Bilensoy E, Cook J, Fernandes E, Haertter S, Kuribayashi R, Mehta M, Paixao P, Seidlitz A, Tampal N, Tsang YC, Walstab J, Wedemeyer R, Welink J, Jiang W. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference. Eur J Pharm Sci. 2025 May 14:107129. doi: 10.1016/j.ejps.2025.107129. Epub ahead of print. PMID: 40379059.

At the 6th International Conference of the Global Bioequivalence Harmonisation Initiative (GBHI), co-organised by the European Federation of Pharmaceutical Sciences (EUFEPS) and the Product Quality Research Institute (PQRI), critical bioequivalence (BE) topics were discussed by pharmaceutical scientists from academia, industry and regulatory agencies.

In Situ Forming, Enzyme-Responsive Peptoid-Peptide Hydrogels: An Advanced Long-Acting Injectable Drug Delivery System

Date:

8/7/24

Citation:

Coulter SM, Pentlavalli S, An Y, Vora LK, Cross ER, Moore JV, Sun H, Schweins R, McCarthy HO, Laverty G. In Situ Forming, Enzyme-Responsive Peptoid-Peptide Hydrogels: An Advanced Long-Acting Injectable Drug Delivery System. J Am Chem Soc. 2024 Aug 7;146(31):21401-21416. doi: 10.1021/jacs.4c03751. Epub 2024 Jun 26. PMID: 38922296; PMCID: PMC11311241.

Long-acting drug delivery systems are promising platforms to improve patient adherence to medication by delivering drugs over sustained periods and removing the need for patients to comply with oral regimens. This research paper provides a proof-of-concept for the development of a new optimized in situ forming injectable depot based on a tetrabenzylamine-tetraglycine-d-lysine-O-phospho-d-tyrosine peptoid-D-peptide formulation ((NPhe)4GGGGk(AZT)y(p)-OH).

Health Topics:

LA/ER Injectable Therapy

Safety and Effectiveness From the CARISEL Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings

Date:

5/6/24

Citation:

Jonsson-Oldenbüttel, Celia MDa,b; Ghosn, Jade MD, PhDc,d; van der Valk, Marc MD, PhDe; Florence, Eric MD, PhDf; Vera, Francisco MD, PhDg; De Wit, Stéphane MDh; Rami, Agathe MDi; Bonnet, Fabrice MD, PhDj; Hocqueloux, Laurent MDk; Hove, Kai MResl; Ait-Khaled, Mounir PhDl; DeMoor, Rebecca MScm; Bontempo, Gilda MDn; Latham, Christine L. MSn; Gutner, Cassidy A. PhDn; Iyer, Supriya MSco; Gill, Martin BScp; Czarnogorski, Maggie MD, MPHn; D’Amico, Ronald DO, MScn; van Wyk, Jean MBChBl. Safety and Effectiveness From the CARISEL Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings. JAIDS Journal of Acquired Immune Deficiency Syndromes ():10.1097/QAI.0000000000003448, May 06, 2024. | DOI: 10.1097/QAI.0000000000003448

Cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months (Q2M) is a complete regimen for the maintenance of HIV-1 virologic suppression. Here, we report Month 12 clinical outcomes in patient study participants (PSPs) in the CARISEL study.

A Novel Method to Optimize Drug Delivery for Parenteral Products Involving New Therapies and Unmet Needs

Date:

5/3/24

Citation:

Khanolkar A, White S, Margerison E. A Novel Method to Optimize Drug Delivery for Parenteral Products Involving New Therapies and Unmet Needs. Pharm Res. 2023 Oct;40(10):2303-2315. doi: 10.1007/s11095-023-03504-1. Epub 2023 Apr 3. PMID: 37012534.

Healthcare trends continue to move from hospital to home and many targeted therapies and precision medicines are now being designed to be self-administered by patients or delivered in a home setting. In the case of long acting injectables and bio-therapeutics, the importance of optimal drug/biologic-device combination in terms of user needs becomes critical for successful clinical outcomes.

A novel formulation enabled transformation of 3 HIV drugs Tenofovir-Lamivudine- Dolutegravir (TLD) from Short-Acting to Long-Acting All-in-One Injectable

Date:

9/28/23

Citation:

Perazzolo, Simone; Stephen, Zacharya; Eguchi, Masaa; Xu, Xiaolina; Fratte, Rachele Dellea; Collier, Ann C.b; Melvin, Ann J.c; Ho, Rodney J.Y.a,d. A novel formulation enabled transformation of 3 HIV drugs tenofovir-lamivudine-dolutegravir (TLD) from short-acting to long-acting all-in-one injectable. AIDS ():10.1097/QAD.0000000000003706, August 25, 2023. | DOI: 10.1097/QAD.0000000000003706

Objective: To develop an injectable dosage form of the daily oral HIV drugs, tenofovir (T), lamivudine (L), and dolutegravir (D), creating a single, complete, all-in-one TLD 3-drug-combination that demonstrates long-acting pharmacokinetics.

Evaluating Islatravir Administered Via Microneedle Array Patch for Long-Acting HIV Pre-exposure Prophylaxis Using Physiologically Based Pharmacokinetic Modelling

Date:

10/27/22

Citation:

Kinvig H, Cottura N, Lloyd A, Frivold C, Mistilis J, Jarrahian C, Siccardi M. Evaluating Islatravir Administered Via Microneedle Array Patch for Long-Acting HIV Pre-exposure Prophylaxis Using Physiologically Based Pharmacokinetic Modelling. Eur J Drug Metab Pharmacokinet. 2022 Sep 30. doi: 10.1007/s13318-022-00793-6. Epub ahead of print. PMID: 36178586.

Technologies for long-acting administration of antiretrovirals (ARVs) for the prevention and treatment of HIV are at the forefront of research initiatives aiming to tackle issues surrounding drug adherence with the current standard of once-daily oral administration. Islatravir (ISL) is an emerging ARV that shows promising characteristics for long-acting prevention and treatment both orally as well as through alternative routes of administration.

Health Topics:

HIV

Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis

Date:

10/27/22

Citation:

Blair HA. Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis. Drugs. 2022 Oct 18. doi: 10.1007/s40265-022-01791-3. Epub ahead of print. PMID: 36255686.

Cabotegravir extended-release (ER) injectable suspension (Apretude™) is the first long-acting injectable option to be approved for HIV-1 pre-exposure prophylaxis (PrEP). As an HIV-1 integrase strand transfer inhibitor, cabotegravir ER injectable suspension prevents DNA integration and inhibits HIV-1 replication.

Health Topics:

HIV

Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California

Date:

8/12/22

Citation:

Bazzi AR, Valasek CJ, Streuli SA, Vera CF, Harvey-Vera A, Philbin MM, Biello KB, Roth AM, Strathdee SA, Pines HA. Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California. AIDS Patient Care STDS. 2022 Jul;36(7):254-262. doi: 10.1089/apc.2022.0068. Epub 2022 Jun 21. PMID: 35727647.

People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood.

Health Topics:

HIV

A long-acting formulation of rifabutin is effective for prevention and treatment of Mycobacterium tuberculosis

Date:

8/8/22

Citation:

Kim M, Johnson CE, Schmalstig AA, Annis A, Wessel SE, Van Horn B, Schauer A, Exner AA, Stout JE, Wahl A, Braunstein M, Victor Garcia J, Kovarova M. A long-acting formulation of rifabutin is effective for prevention and treatment of Mycobacterium tuberculosis. Nat Commun. 2022 Aug 8;13(1):4455. doi: 10.1038/s41467-022-32043-3. PMID: 35941109.

Tuberculosis (TB) is a communicable disease caused by Mycobacterium tuberculosis (Mtb) and is a major cause of morbidity and mortality. Successful treatment requires strict adherence to drug regimens for prolonged periods of time. Long-acting (LA) delivery systems have the potential to improve adherence.

Health Topics:

Tuberculosis

Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review

Date:

4/18/22

Citation:

Sued O, Nardi N, Spadaccini L. Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review. Curr Opin HIV AIDS. 2022 Apr 18. doi: 10.1097/COH.0000000000000734. Epub ahead of print. PMID: 35438662.

The objective of the current review is to update the perceptions of key populations and PLWH about LA, based on their opinion, acceptability, and willingness to use it.

Health Topics:

HIV

Pre-exposure Prophylaxis (PrEP)

Recent Publications

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