IVRT and IVPT: Pivotal Tools in Topical Product Development

Topical products are liquid or semi-solid dosage forms applied to the skin, encompassing both integumentary and mucosal membranes. They can be developed as liquids, gels, creams, ointments and lotions.  Semisolid dosage forms can be viewed as extended-release preparations, with the rate of drug release influenced by the formulation and manufacturing process. Evaluation of Topical products […]

Topical Dosage Forms: Product Development Overview

Topical dosage forms are medications applied directly to the body surfaces, primarily the skin or mucous membranes. Topical products are typically liquid or semi-solid dosage forms that are widely used due to ease of application.  There are many advantages of topical route of delivery including elimination of hepatic first pass metabolism, drug deliver directly to […]

Heterocyclic Compounds, the Backbone of Small Molecule Therapeutics

In the ever-evolving landscape of pharmaceuticals and drug discovery, researchers are constantly on the lookout for innovative compounds that can target diseases more effectively with fewer side effects. One class of compounds that continues to be critical in this pursuit is heterocyclic molecules. These compounds are characterized by the presence of at least one ring […]

Pharmaceutical Suspensions – Part 2: Formulation Development

Early Preformulation Studies For the development of a robust suspension product, several factors must be considered early on during product development.  These include API particle size, particle density, viscosity and specific gravity of the media, buffer capacity, hydrophilicity / hydrophobicity, zeta potential, pH-solubility and stability profile of the API, taste masking requirements and preservative efficacy.  […]

Pharmaceutical Suspension Formulations – Part 1: An Overview of Key Advantages and Desirable Properties

What are Pharmaceutical Suspensions Liquid oral dosage forms such as solutions and suspensions are often preferred for pediatric or geriatric patients that find it difficult to swallow tablets or capsules.  Most pharmaceutical suspensions are coarse dispersions of solid insoluble drug particles dispersed in a liquid vehicle.  Besides oral administration, suspensions are also prepared for other […]

Buccal Delivery Systems (Part 3) – Improving Bioavailability through Buccal Route

Poor bioavailability is a common problem for a majority of new drugs in the pipeline of pharmaceutical companies.  This can be due to a variety of reasons including poor solubility, permeability, susceptibility to low pH environment, enzymatic degradation or hepatic first pass metabolism.  An estimated 70-80 % of pipeline drugs under development fall under BCS […]

Buccal Delivery Systems | Part 2: Applications and Dosage Forms

Why Buccal Delivery  Buccal cavity in the mouth is an attractive route for administration of drugs that offers numerous benefits such as rapid product development timelines, reduced cost of therapy, ease of administration and improved adherence to therapy. It is especially useful for administration of drugs that undergo extensive first pass metabolism. Increased bioavailability can […]

Buccal Delivery Systems | Part 1: Opportunities and Challenges

The buccal region is the mouth cavity offers unique benefits for delivery of drugs over conventional more popular routes of administration such as oral, parenteral and topical.  Buccal mucosa is highly perfused with blood vessels which enables rapid absorption and improved bioavailability of many drugs for both local and systemic treatments.  It combines the beneficial […]

The science of pharmaceutical taste masking

Taste masking is often used in the pharmaceutical industry to make bitter or unpleasant-tasting drugs more palatable. This is especially important for pediatric populations or geriatric populations.  Taste masking can be achieved through a variety of methods, including: Adding sweeteners and flavors: Sweeteners and flavors can be added to mask the taste of a drug. […]

Will the US FDA accept foreign clinical trials?

In the past, the FDA only accepted clinical studies that were conducted in the United States. However, in recent years, the FDA has begun to accept clinical studies that were conducted in other countries. This is because the FDA recognizes that high-quality clinical studies can be conducted in other countries, and that accepting such data […]