4,935 results match your criteria long-acting injectable

Interest in long-acting injectable buprenorphine among syringe services program participants.

J Opioid Manag 2021 ;17(7):59-67

Department of Internal Medicine, Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York. ORCID: https://orcid.org/0000-0001-5651-5589.

Objective: To examine syringe services program (SSP) participants' interest in long-acting injectable buprenorphine.

Design: SSP participants completed a 136-item questionnaire by phone. Items assessed quantitative ratings of interest in sublingual and injectable buprenorphine, preference for sublingual versus injectable buprenorphine, and reasons for preferences. Read More

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September 2021

Pharmacokinetic and Safety Profile of the Novel HIV Non-Nucleoside Reverse Transcriptase Inhibitor MK-8507 in Adults without HIV.

Antimicrob Agents Chemother 2021 Sep 13:AAC0093521. Epub 2021 Sep 13.

Merck & Co., Inc., Kenilworth, NJ, USA.

MK-8507 is a novel HIV-1 non-nucleoside reverse transcriptase inhibitor in clinical development with potential for once-weekly oral administration for the treatment of HIV-1 infection. Two randomized, double-blind, placebo-controlled phase 1 studies in adults without HIV-1 evaluated the safety, tolerability, and pharmacokinetics of single and multiple doses of MK-8507; drug interaction with midazolam (a cytochrome P450 3A4 substrate) and food effect were also assessed. In Study 1, 16 participants received oral ascending single doses of MK-8507 (2-400 mg) or placebo in an alternating fashion. Read More

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September 2021

Clozapine resistant schizophrenia: Newer avenues of management.

World J Psychiatry 2021 Aug 19;11(8):429-448. Epub 2021 Aug 19.

Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India.

About 40%-70% of the patients with treatment-resistant schizophrenia have a poor response to adequate treatment with clozapine. The impact of clozapine-resistant schizophrenia (CRS) is even greater than that of treatment resistance in terms of severe and persistent symptoms, relapses and hospitalizations, poorer quality of life, and healthcare costs. Such serious consequences often compel clinicians to try different augmentation strategies to enhance the inadequate clozapine response in CRS. Read More

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Randomised, double-blind comparison of a fixed co-formulation of intra-articular polynucleotides and hyaluronic acid versus hyaluronic acid alone in the treatment of knee osteoarthritis: two-year follow-up.

BMC Musculoskelet Disord 2021 Sep 12;22(1):773. Epub 2021 Sep 12.

Reconstructive Orthopaedic Surgery and Innovative Techniques - Musculoskeletal Tissue Bank, IRCCS Istituto Ortopedico Rizzoli, Via G.C. Pupilli 1, 40136, Bologna, Italy.

Background: A first-year interim analysis of this two-year study suggested that intra-articular injections of highly purified, natural-origin polynucleotides and hyaluronic acid (HA) as a fixed combination (PNHA) might improve knee function and joint pain more effectively than HA alone in patients with knee osteoarthritis (OA). The purpose of the second-year analysis herein described was to verify whether the first-year interim outcomes persist over the whole two-year period.

Methods: Randomised, double-blind, HA-controlled clinical trial in 100 knee OA patients (98 randomised, 79 completing the study) in a high-specialisation tertiary care setting. Read More

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September 2021

Population pharmacokinetics of the rilpivirine long-acting formulation after intramuscular dosing in healthy subjects and people living with HIV.

J Antimicrob Chemother 2021 Sep 12. Epub 2021 Sep 12.

Clinical Pharmacology and Pharmacometrics, Janssen Research and Development, Beerse, Belgium.

Objectives: To characterize the population pharmacokinetics of the rilpivirine long-acting (LA) formulation after intramuscular administration.

Methods: Rich and sparse rilpivirine plasma concentration data were obtained from seven clinical studies. In total, 18 261 rilpivirine samples were collected from 986 subjects (131 healthy subjects from Phase I studies and 855 people living with HIV from Phase IIb/III studies). Read More

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September 2021

APB-F1, a long-acting feline granulocyte colony-stimulating factor fusion protein, created by exploiting FL335, a chimeric Fab specific for feline serum albumin.

Vet Immunol Immunopathol 2021 Aug 28;240:110322. Epub 2021 Aug 28.

Aprilbio Co., Rm 602, Biomedical Science Building, Kangwon National University, Chuncheon, Republic of Korea; Department of Systems Immunology, Division of Biomedical Convergence, College of Biomedical Science, Kangwon National University, Chuncheon, Republic of Korea. Electronic address:

Off-label use of a human granulocyte colony stimulating factor (hG-CSF) has been allowed to treat dogs and cats with neutropenia. However, repeated administration of hG-CSF induces undesirable anti-drug antibody (ADA) responses, implying the necessity of animal-derived G-CSF as a therapeutic reagent, preferably with a long-acting capability. Herein, we generated a recombinant fusion protein by genetically combining FL335, a chimeric Fab specific for feline serum albumin (FSA), and feline G-CSF (fG-CSF), with the ultimate goal of developing a long-acting therapeutic fG-CSF for cats. Read More

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Long-acting antiretrovirals: a new era for the management and prevention of HIV infection.

J Antimicrob Chemother 2021 Sep 9. Epub 2021 Sep 9.

Service and Laboratory of Clinical Pharmacology, Department of Laboratory Medicine and Pathology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.

The long-acting antiretroviral cabotegravir and rilpivirine combination has just received FDA, EMA and Health Canada approval. This novel drug delivery approach is about to revolutionize the therapy of people living with HIV, decreasing the 365 daily pill burden to only six intramuscular injections per year. In addition, islatravir, a first-in-class nucleoside reverse transcriptase translocation inhibitor, is intended to be formulated as an implant with a dosing interval of 1 year or more. Read More

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September 2021

Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail.

JAMA Netw Open 2021 Sep 1;4(9):e2123032. Epub 2021 Sep 1.

Department of Medicine, New York University Grossman School of Medicine, New York.

Importance: Extended-release buprenorphine (XRB), a monthly injectable long-acting opioid use disorder (OUD) treatment, has not been studied for use in corrections facilities.

Objective: To compare treatment retention following release from jail among adults receiving daily sublingual buprenorphine-naloxone (SLB) vs those receiving XRB.

Design, Setting, And Participants: This open-label, randomized comparative effectiveness study included 52 incarcerated adults in New York City observed for 8 weeks postrelease between June 2019 and May 2020. Read More

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September 2021

Patients' satisfaction with long-acting injectable somatostatin analog therapy for neuroendocrine tumors.

J Patient Rep Outcomes 2021 Sep 7;5(1):82. Epub 2021 Sep 7.

Intermountain Medical Center, Murry, UT, USA.

Background: Long-acting somatostatin analogs (LA SSAs) are approved and recommended for the treatment of patients with advanced neuroendocrine tumors (NETs). Given the long duration of therapy and differences in administration routes, it is important to understand patients' experiences with receiving LA SSA injections.

Methods: We conducted a serial survey, informed by qualitative interviews with eight patients treated with LA SSAs and two nurses who administer LA SSA injections, among patients undergoing LA SSA treatment over a 28-day period (administered at baseline and 14 days and 28 days after injection). Read More

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September 2021

Liraglutide Activation of AMP-Activated Protein Kinase-Hypoxia Inducible Factor-1α-Heme Oxygenase-1 Signaling Promotes Wound Healing by Preventing Endothelial Dysfunction in Diabetic Mice.

Front Physiol 2021 16;12:660263. Epub 2021 Aug 16.

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.

: Diabetic foot ulcers (DFUs) present a major challenge in clinical practice, and hyperglycemia-induced angiogenesis disturbance and endothelial dysfunction likely exacerbate DFUs. The long-acting glucagon-like peptide-1 (GLP-1) analog liraglutide (Lira) is a potential activator of AMP-activated protein kinase (AMPK) that appears to enhance endothelial function and have substantial pro-angiogenesis and antioxidant stress effects. Therefore, in this study, we aimed to investigate whether the protective role of Lira in diabetic wound healing acts against the mechanisms underlying hyperglycemia-induced endothelial dysfunction and angiogenesis disturbance. Read More

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Sexually transmitted infections and depot medroxyprogesterone acetate do not impact protection from SHIV acquisition by long-acting cabotegravir in macaques.

AIDS 2021 Aug 20. Epub 2021 Aug 20.

Division of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, GA Libra Management Group, Atlanta, GA, USA Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA Division of High-Consequence Pathogens and Pathology ViiV Healthcare, Research Triangle Park, NC 27709, USA.

Objective: We had previously shown that long-acting cabotegravir (CAB-LA) injections fully protected macaques from vaginal simian HIV (SHIV) infection. Here, we reassessed CAB-LA efficacy in the presence of depot medroxyprogesterone acetate and multiple sexually transmitted infections (STI) that are known to increase HIV susceptibility in women.

Design: Two macaque models of increasing vaginal STI severity were used for efficacy assessment. Read More

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Polymeric long-acting drug delivery systems (LADDS) for treatment of chronic diseases: Inserts, patches, wafers, and implants.

Adv Drug Deliv Rev 2021 Sep 1;177:113957. Epub 2021 Sep 1.

Drug Discovery, Delivery and Patient Care Theme (DDDPC), Faculty of Science, Engineering and Computing, Kingston University London, Penrhyn Road, Kingston upon Thames, UK; School of Pharmacy, The University of Auckland, Auckland, New Zealand. Electronic address:

Non-oral long-acting drug delivery systems (LADDS) encompass a range of technologies for precisely delivering drug molecules into target tissues either through the systemic circulation or via localized injections for treating chronic diseases like diabetes, cancer, and brain disorders as well as for age-related eye diseases. LADDS have been shown to prolong drug release from 24 h up to 3 years depending on characteristics of the drug and delivery system. LADDS can offer potentially safer, more effective, and patient friendly treatment options compared to more invasive modes of drug administration such as repeated injections or minor surgical intervention. Read More

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September 2021

Population pharmacokinetics and dosing of long-acting injectable antipsychotics.

J Psychiatry Neurosci 2021 Sep 1;46(5):E516-E517. Epub 2021 Sep 1.

From the Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia (Kim, Barr); the British Columbia Mental Health & Substance Use Services Research Institute (Kim, Barr, Procyshyn); the Lower Mainland Pharmacy Services and Faculty of Pharmaceutical Sciences, University of British Columbia (Rafizadeh); and the Department of Psychiatry, University of British Columbia (Procyshyn), Vancouver, BC, Canada.

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September 2021

Cardiovascular Disease, Hypogonadism and Erectile Dysfunction: Early Detection, Prevention and the Positive Effects of Long-Term Testosterone Treatment: Prospective Observational, Real-Life Data.

Vasc Health Risk Manag 2021 24;17:497-508. Epub 2021 Aug 24.

Hamad Medical Corporation, Department of Surgery, Division of Urology/Andrology and Section of Surgical Research, Doha, Qatar.

Purpose: Erectile dysfunction (ED) is associated with testosterone deficiency and is a symptom of functional hypogonadism. A correlation between ED and cardiovascular disease (CVD) has been recognized, and ED has been proposed as an early marker of CVD. However, the relationship between ED and CVD risk in hypogonadism requires clarification and whether testosterone therapy (TTh) can be a beneficial treatment strategy, but long-term data are limited. Read More

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Lipophilic Conjugates of Drugs: A Tool to Improve Drug Pharmacokinetic and Therapeutic Profiles.

Pharm Res 2021 Aug 31. Epub 2021 Aug 31.

Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, VIC, 3052, Australia.

Lipophilic conjugates (LCs) of small molecule drugs have been used widely in clinical and pre-clinical studies to achieve a number of pharmacokinetic and therapeutic benefits. For example, lipophilic derivatives of drugs are employed in several long acting injectable products to provide sustained drug exposure for hormone replacement therapy and to treat conditions such as neuropsychiatric diseases. LCs can also be used to modulate drug metabolism, and to enhance drug permeation across membranes, either by increasing lipophilicity to enhance passive diffusion or by increasing protein-mediated active transport. Read More

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Long-acting injectable antipsychotic medications in pregnancy: A review.

J Acad Consult Liaison Psychiatry 2021 Aug 27. Epub 2021 Aug 27.

LAC+USC Medical Center, 2051 Marengo Street, Los Angeles, CA 90033, USA.

Background: Long-acting injectable antipsychotic medications (LAIs) are an evidence-based treatment option for people with severe mental illness (SMI). While women with SMI who are prescribed LAIs can become pregnant, there is a dearth of research examining the safety of these medication formulations during pregnancy. This article summarizes available literature on the use of LAIs in pregnancy to help inform clinical decisions and guide future research. Read More

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Improvements of Frontotemporal Cerebral Blood Flow and Cognitive Functioning in Patients With First Episode of Schizophrenia Treated With Long-Acting Aripiprazole.

J Clin Psychopharmacol 2021 Aug 26. Epub 2021 Aug 26.

From the Department of Psychiatry, University Hospital Centre Sestre Milosrdnice School of Medicine, Catholic University of Croatia Department of Oncology and Nuclear Medicine, University Hospital Centre Sestre Milosrdnice, Zagreb, Croatia.

Purpose/background: Frontal and temporal cerebral blood flow (CBF) changes are the most common impairments of CBF described in patients with schizophrenia. Those impairments have also been associated with cognitive deficits, a hallmark of schizophrenia. In light of that fact, treatment interventions should target cognitive deficits to prevent chronic disability. Read More

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The Relation between the Plasma Concentrations of Long-Acting Atypical Antipsychotics and Clinical Effectiveness in Patients Affected by Schizophrenia or Schizoaffective Disorder: A Comprehensive Overview.

Curr Pharm Des 2021 Aug 29. Epub 2021 Aug 29.

Department of Neurosciences and Mental Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via F. Sforza 35, 20122, Milan. Italy.

Atypical antipsychotic depot medications are currently recommended for patients with schizophrenia (SCZ) to prevent relapse and ameliorate the long-term prognosis of these patients. This review critically summarizes the available data about the association between the plasma concentrations of long-acting SecondGeneration Antipsychotics (SGAs) and the clinical effectiveness of these compounds in patients affected by SCZ or schizoaffective disorder. Our question is if the measurement of these concentrations can be helpful for clinicians in predicting treatment response and clinical stabilization of patients. Read More

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Ethical issues in establishing the efficacy and safety of long-acting injectable pre-exposure prophylaxis for HIV prevention: the HPTN 083 trial.

Lancet HIV 2021 Aug 26. Epub 2021 Aug 26.

UCLA Center for Clinical AIDS Research and Education, Los Angeles, CA, USA.

Two multinational clinical trials have shown safety and efficacy of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). These results will alter the landscape of HIV prevention and related research. Nevertheless, designing and conducting this research involved several ethical issues. Read More

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High-level resistance to bictegravir and cabotegravir in subtype A- and D-infected HIV-1 patients failing raltegravir with multiple resistance mutations.

J Antimicrob Chemother 2021 Aug 28. Epub 2021 Aug 28.

Department of Microbiology and Immunology, Western University, London, Canada.

Objectives: The second-generation integrase strand transfer inhibitor (INSTI) bictegravir is becoming accessible in low- and middle-income countries (LMICs), and another INSTI, cabotegravir, has recently been approved as a long-acting injectable. Data on bictegravir and cabotegravir susceptibility in raltegravir-experienced HIV-1 subtype A- and D-infected patients carrying drug resistance mutations (DRMs) remain very scarce in LMICs.

Patients And Methods: HIV-1 integrase (IN)-recombinant viruses from eight patients failing raltegravir-based third-line therapy in Uganda were genotypically and phenotypically tested for susceptibility to bictegravir and cabotegravir. Read More

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Tracing the affordances of long-acting injectable depot buprenorphine: A qualitative study of patients' experiences in Australia.

Drug Alcohol Depend 2021 Aug 11;227:108959. Epub 2021 Aug 11.

Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, VIC, Australia; Turning Point, Eastern Health, Richmond, VIC, Australia. Electronic address:

Background: Long-acting injectable depot buprenorphine is an important new treatment option for the management of opioid dependence, delivering therapeutic doses in weekly or monthly formulations. Depot buprenorphine aims to overcome challenges associated with traditional opioid agonist therapy (OAT), including: poor patient adherence; inconvenience of regular attendance for dosing; and, risk of non-medical use of takeaway doses. However, little is known about patients' experiences of depot buprenorphine. Read More

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Pharmacokinetic, Safety, and Pharmacodynamic Properties of Teverelix Trifluoroacetate, a Novel Gonadotropin-Releasing Hormone Antagonist, in Healthy Adult Subjects.

Clin Pharmacol Drug Dev 2021 Aug 26. Epub 2021 Aug 26.

Antev Ltd, London, UK.

Teverelix trifluoroacetate is a decapeptide, gonadotropin-releasing hormone antagonist that binds competitively and reversibly to gonadotropin-releasing hormone receptors in the pituitary gland, resulting in immediate suppression of luteinizing hormone and follicle-stimulating hormone, which in turn causes a very rapid decrease in testosterone production in the Leydig cells of the testes in men and in estradiol in the ovaries in women. This phase 1 clinical study was an open-label, parallel-design, single-center, single-dose study in older, healthy male subjects. Following injection, teverelix is released into the systemic circulation in a biphasic manner. Read More

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PLGA/PLA-Based Long-Acting Injectable Depot Microspheres in Clinical Use: Production and Characterization Overview for Protein/Peptide Delivery.

Int J Mol Sci 2021 Aug 18;22(16). Epub 2021 Aug 18.

College of Pharmacy and Pharmaceutical Sciences-Institute of Public Health, Florida A&M University, Tallahassee, FL 32307, USA.

Over the past few decades, long acting injectable (LAI) depots of polylactide-co-glycolide (PLGA) or polylactic acid (PLA) based microspheres have been developed for controlled drug delivery to reduce dosing frequency and to improve the therapeutic effects. Biopharmaceuticals such as proteins and peptides are encapsulated in the microspheres to increase their bioavailability and provide a long release period (days or months) with constant drug plasma concentration. The biodegradable and biocompatible properties of PLGA/PLA polymers, including but not limited to molecular weight, end group, lactide to glycolide ratio, and minor manufacturing changes, could greatly affect the quality attributes of microsphere formulations such as release profile, size, encapsulation efficiency, and bioactivity of biopharmaceuticals. Read More

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Greater than the Sum: Applying Daily-Dose Equivalents to Antipsychotic Prescription Claims to Study Real-World Effects.

Front Pharmacol 2021 6;12:709349. Epub 2021 Aug 6.

ICES, Toronto, ON, Canada.

Traditional methods to standardize exposures in pharmacoepidemiologic studies, like defined daily-doses, may be inadequate to capture drug class effects when there are many in-class medications, formulations, and administration routes. Antipsychotic medications are one example of a drug class with these complexities. Direct dose conversion methods are pharmacologically-based but often overlooked, potentially for lack of real-world guidance and examples of their implementation. Read More

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Long Acting Injectables and their Correlation with Subjectivity in Schizophrenia Spectrum Disorder.

Psychopharmacol Bull 2021 Jun;51(3):27-37

Caselli, MD, PhD Student, Gasparini, MD, PhD Student, Ielmini, MD, PhD Student, Lucca, MD, PhD Student, Amorosi, MD, Poloni, MD, PhD, Researcher, Callegari, MD, PhD, Associate Professor, Department of Medicine and Surgery, Division of Psychiatry, University of Insubria, Varese, Italy.

Nowadays, mental illness can no longer be considered as a mere list of symptoms corresponding to localized brain dysfunctions but rather as a disturbance of the patient's subjectivity. Thus, a solid, qualitative study of patients' subjectivity could represent a useful tool in the complex evaluation of efficacy of pharmacotherapy in schizophrenic persons. In this perspective, authors performed a phenomenological oriented investigation on 49 patients, diagnosed with schizophrenia spectrum disorder, who were receiving long-acting injectable (LAI) antipsychotic therapy. Read More

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Can a 'Shot' Help Prevent Youth Re-Incarceration? Case Report on Use of a Long-Acting Injectable Antipsychotic in Incarcerated Youth.

Psychopharmacol Bull 2021 Jun;51(3):8-9

Aggarwal, MD, Lindegaard, BA, Department of Psychiatry, University of Missouri, Columbia, MO.

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Modulation of the clinically accessible gelation time using glucono-d-lactone and pyridoxal 5'-phosphate for long-acting alginate in situ forming gel injectable.

Carbohydr Polym 2021 Nov 17;272:118453. Epub 2021 Jul 17.

College of Pharmacy, Ajou University, Suwon 16499, Republic of Korea; Institute of Pharmaceutical Science and Technology, Ajou University, Suwon 16499, Republic of Korea. Electronic address:

The purpose of this study was to design alginate in situ forming gel (ISFG) injectable with clinically acceptable gelation time and controlled release of hydrophobic drug. Milled or unmilled paliperidone palmitate (PPP) was used. The gelation time was controlled by varying the ratios of glucono-d-lactone (GDL) and pyridoxal 5'-phosphate (PLP) in prefilled alginate solution mixtures (ASMs) containing PPP, CaCO, GDL and PLP for clinically acceptable injectability. Read More

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November 2021

Novel injectable progesterone-loaded nanoparticles embedded in SAIB-PLGA in situ depot system for sustained drug release.

Int J Pharm 2021 Aug 18;607:121021. Epub 2021 Aug 18.

Department of Pharmaceutics Science, Shenyang Pharmaceutical University, Shenyang 110016, China. Electronic address:

Poly (lactic-co-glycolic acid) (PLGA) nanoparticles (NPs) have attracted considerable interest in the medical community as a sustained-release drug delivery system for localized treatment. However, it is currently a grand challenge to simultaneously achieve low-dose drugs, stable and prolonged drug release, and long-term retention circumventing uptake by macrophages. Here, we construct a solvent-exchange in-situ depot system by incorporating progesterone (PRG) loaded PLGA NPs into a sucrose acetate isobutyrate (SAIB) and PLGA matrix for the long term treatment of Assisted Reproductive Technology (ART). Read More

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Cabenuva®: Differentiated service delivery and the community Pharmacists' roles in achieving UNAIDS 2030 target in Nigeria.

Saudi Pharm J 2021 Aug 15;29(8):815-819. Epub 2021 Jun 15.

Howard University Global Initiative Nigeria, Calabar, Cross River State, Nigeria.

The approval of the novel long-acting HIV injection; Cabenuva®- Cabotegravir and Rilpivirine injectable formulation) and the recent call by the World Health Organization for promoting community-based ART management, underscore the remarkable progress towards meeting the Joint United Nations Programme on HIV/AIDS (UNAIDS) 95-95-95 targets by 2030. As the availability of antiretroviral therapy (ART) for the treatment of HIV/AIDS has increased in resource-limited settings, there has been a move to develop and implement alternative treatment delivery models such as Differentiated Service Delivery (DSD) in high prevalence countries to meet the global targets for HIV treatment while maintaining the quality of care. However, there is limited data on the involvement of community pharmacies in the delivery of ART within the community. Read More

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