APR March 2024 - 63
Nanoparticles with pH-Triggered
Drug Release;
S. Chopra, R. Karnik, A. Wang, O.C.
Farokhzad, and X.Q. Zhang; The Brigham
and Women's Hospital, and Massachusetts
Institute of Technology, U.S.A.; U.S.
Patent # 11,833,255; December 5, 2023
Some pharmaceuticals are sensitive to conditions found in the
gastrointestinal tract such as wide fluctuations in pH and enzyme
activity. For example, therapeutic biologics include large protein
molecules such as insulin, calcitonin etc. Their large size, and
sensitivity to the complex gastrointestinal environment with of a
wide range of pH and enzyme activity, makes it challenging to
deliver these biologics orally. Rapid release of the payload is one
way of addressing the problem of delivering sensitive drugs to
the body. The present disclosure provides pH-responsive nano
particles (NPs) and methods of making them. The invention
ensured small NP diameter and satisfactory drug loading. The
drug and the NP survive the changes in pH in the complex
environment of the gastrointestinal tract, and it also triggers a
quick release of a majority of the drug before the NP is excreted
from the body.
Use of Sublingual
Dexmedetomidine for the
Treatment of Agitation;
K. Nandbalan, F. Yocca, S. Sharma,
H. Negi, and D. Saini; Bioxcel
Therapeutics, U.S.A.; U.S. Patent #
11,839,604; December 12, 2023.
Agitation is a term that can refer to many behavioral
disorders and can be associated with neurodegenerative
and neuropsychiatric disorders such as dementia and
schizophrenia. The treatments for agitation in patients with
such conditions are still limited. The present invention provides
a method of treating agitation or the signs of agitation
in a subject comprising sublingual administration of an
effective amount of dexmedetomidine or a pharmaceutically
acceptable salt thereof without causing significant sedation.
Composition and Methods for
Stimulating Clearance of
Amyloid-Beta Protein;
K. Pahan, and A. Ghosh; Rush
University Medical Center, U.S.A.; U.S.
Patent # 11,844,767; December 19, 2023.
Astrocytes are principal cells responsible for maintaining
the brain homeostasis. Additionally, these glial cells are also
involved in homo-cellular and hetero-cellular signaling and
metabolism.
This invention describes compositions and
methods for stimulating astroglial uptake and degradation of
amyloid-beta protein aggregates. They used a combination
of vitamin A and an agonist of proliferator-activated receptor
alpha (PPAR alpha). The inventor used gemfibrozil as the
PPAR alpha. The combination can be used to treat Alzheimer's
disease or Parkinsons' disease.
Lower Dosage Strength Imiquimod
Formulations and Short Dosing
Regimens for Treating Genital and
Perianal Warts;
M.T. Nordsiek, and J. J. Gregory; Medicis
Pharma, USA; U.S. Patent # 11,850,245;
December 26, 2023.
This patent describes pharmaceutical formulations and methods for
the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine
or 1-(2-methylpropyl)-1H-imidazo[4,5c]quinolin4-amine],
i.e., imiquimod, to treat genital/perianal warts with
shorter durations of therapy. Current FDA-approved Aldara® 5%
imiquimod cream for EGWs (external genital and perianal warts/
condyloma acuminate) have limitations like unsimplified (once
a day, 3 times per week) and lengthy dosing regimen (Median
time = 10 weeks). If applied too thickly or generously, Aldara®
5% imiquimod cream can cause site or local skin reactions. Other
symptoms, such as perianal itching or systemic effects such as flulike
symptoms, may also occur. Present invention provides novel
and improved imiquimod treatment regimens of short duration
(for up to 8 weeks), lower dosage strength (between 1% and 4.25%)
and simplified dosing regimens to treat EGWs. (1 application daily).
www.americanpharmaceuticalreview.com |
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APR March 2024
Table of Contents for the Digital Edition of APR March 2024
Message from the Editor
Editorial Advisory Board
BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
An Interview with Dan Smithey, PhD President & CEO, Serán
FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
QC Corner - Enhancing Material and Equipment Availability in Production Isolators
BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
DRUG DELIVERY - Your Nails and You
DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
Event Preview - CPHI North America
Event Preview - Excipient World 2024
P.I.N. Points
Advertiser's Index
APR March 2024 - CoverTip01
APR March 2024 - CoverTip02
APR March 2024 - Cover1
APR March 2024 - Cover2
APR March 2024 - 1
APR March 2024 - 2
APR March 2024 - 3
APR March 2024 - 4
APR March 2024 - 5
APR March 2024 - Message from the Editor
APR March 2024 - Editorial Advisory Board
APR March 2024 - BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
APR March 2024 - 9
APR March 2024 - 10
APR March 2024 - 11
APR March 2024 - 12
APR March 2024 - 13
APR March 2024 - MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
APR March 2024 - 15
APR March 2024 - 16
APR March 2024 - 17
APR March 2024 - 18
APR March 2024 - FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
APR March 2024 - 20
APR March 2024 - 21
APR March 2024 - 22
APR March 2024 - 23
APR March 2024 - FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
APR March 2024 - 25
APR March 2024 - 26
APR March 2024 - 27
APR March 2024 - An Interview with Dan Smithey, PhD President & CEO, Serán
APR March 2024 - 29
APR March 2024 - 30
APR March 2024 - FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
APR March 2024 - 32
APR March 2024 - 33
APR March 2024 - QC Corner - Enhancing Material and Equipment Availability in Production Isolators
APR March 2024 - 35
APR March 2024 - BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
APR March 2024 - 37
APR March 2024 - 38
APR March 2024 - 39
APR March 2024 - Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
APR March 2024 - 41
APR March 2024 - MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
APR March 2024 - 43
APR March 2024 - Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
APR March 2024 - 45
APR March 2024 - 46
APR March 2024 - 47
APR March 2024 - DRUG DELIVERY - Your Nails and You
APR March 2024 - 49
APR March 2024 - 50
APR March 2024 - 51
APR March 2024 - DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
APR March 2024 - 53
APR March 2024 - 54
APR March 2024 - 55
APR March 2024 - FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
APR March 2024 - 57
APR March 2024 - Event Preview - CPHI North America
APR March 2024 - 59
APR March 2024 - Event Preview - Excipient World 2024
APR March 2024 - 61
APR March 2024 - P.I.N. Points
APR March 2024 - 63
APR March 2024 - Advertiser's Index
APR March 2024 - Cover3
APR March 2024 - Cover4
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