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Drug Delivery: Overview

Drug Delivery: Overview

The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
Enteral delivery involves administering drugs directly through swallowing, sublingual placement, or buccal application. Orally administered drugs predominantly navigate the...

Drug Delivery: Miscellaneous Routes

Drug Delivery: Miscellaneous Routes

Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection, and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...

Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Drug Delivery: Parenteral Route

Drug Delivery: Parenteral Route

The parenteral route is a critical method of drug administration. It delivers compounds directly into the systemic circulation and bypasses the gastrointestinal tract. This approach is particularly advantageous for drugs that exhibit poor absorption or instability when administered orally.
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...

Drug Delivery: Enteral Route

Drug Delivery: Enteral Route

The enteral drug administration involves three primary routes: oral, sublingual, and buccal. Oral ingestion is the most prevalent, safe, economical, and convenient method for drug administration. However, it has certain drawbacks, including limited absorption due to the drug's low water solubility or poor membrane permeability, possible emesis from GI mucosa irritation, destruction of drugs by digestive enzymes or low gastric pH, and irregular absorption along with food or other drugs.

Drug Administration and Therapy Phases: Overview

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
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Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods

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Novel Drug Delivery Systems Approved by USFDA from 2019 to 2023: A Comprehensive Review.

Anfal F Almazyad¹, Nazrul Haq², Ibrahim A Alsarra²

¹Joint Program Council in Drug Regulatory Affairs, Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia.

Current Drug Delivery

|September 5, 2025

Summary

Recent advancements in novel drug delivery systems (NDDS) have led to US Food and Drug Administration (USFDA) approvals, enhancing drug efficacy and patient convenience. This review summarizes key NDDS innovations from 2019-2023 across various delivery routes.

Keywords:

Antibody drug-conjugate USFDA.block copolymer micelles marketed products novel drug delivery systems patents

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Area of Science:

Pharmaceutical Sciences
Biotechnology
Drug Delivery Technologies

Background:

Novel Drug Delivery Systems (NDDS) are crucial for improving therapeutic outcomes and patient compliance.
Significant progress in NDDS necessitates a review of recent regulatory approvals.
Understanding approved NDDS is vital for future pharmaceutical innovation.

Purpose of the Study:

To comprehensively review US Food and Drug Administration (USFDA)-approved NDDS from 2019 to 2023.
To categorize and analyze these NDDS by their delivery routes (oral, injectable, transdermal, etc.).
To discuss mechanisms, benefits, limitations, clinical applications, and future prospects of approved NDDS.

Main Methods:

Literature search across PubMed, Scopus, USFDA databases, and patent websites.
Systematic review and categorization of approved NDDS based on administration route.
Detailed analysis of each NDDS, including mechanism of action, advantages, and limitations.

Main Results:

Multiple innovative NDDS technologies received USFDA approval between 2019 and 2023.
Approved NDDS demonstrate enhanced drug stability, bioavailability, and controlled release.
These systems offer improved therapeutic efficacy and patient convenience across diverse delivery routes.

Conclusions:

The period 2019-2023 witnessed substantial progress in NDDS, marked by significant USFDA approvals.
Approved NDDS represent key advancements in drug formulation and delivery strategies.
This review serves as a valuable resource for guiding future research and development in patient-centric drug delivery.