Excipients

Examines issues in excipients and non-API formulation—including bio-uptake/bioavailability. Looks at every aspect of non-API components. Discusses global regulatory issues impacting excipients and formulations. Investigates uses of different ways to use formulations—for instance, co-processed excipients. Forecasts potential new excipients under development. Looks into different ways to use existing excipients for filling, coating and binding, among others.

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Advancing poorly soluble drugs to the clinic: Rapid development of tablet formulations using milligrams of API
March 06, 2020
Up to 70 percent of active pharmaceutical ingredients (APIs) in today’s drug pipeline are poorly soluble, which complicates delivery and results in poor bioavailability. Organic solvents, such as dimethyl sulfoxide (DMSO), are toxic and incompatible ... read more
Excipients: Formulation Effects on Tablet Surface Properties and Film Coating Adhesion
October 10, 2019
Aqueous film coatings can enhance the appearance, stability, swallowability, and brand identity of pharmaceutical tablets. Coatings can also be used to mask the taste of a bitter or otherwise unpleasant active pharmaceutical ingredient or control its... read more
Quality by Design: Using Multivariate Analysis of Batch-to-Batch Excipient Variation to Reduce Risk
October 10, 2019
In the pharmaceutical industry, a detailed understanding of the impact of raw material variation on a drug product’s performance and manufacturing is key. Drug products consist of an active pharmaceutical ingredient (API) as well as many functional ... read more
Eye on Excipients: Pros and Cons of Direct-Compression Tableting
October 10, 2019
Compressed tablets continue to be the most popular pharmaceutical dosage form. They provide higher content uniformity and are easier to administer at home than syrups or suspensions. They also provide superior chemical, microbiological, and ... read more
Eye on Excipients: Easing Compaction and Compression
September 19, 2019
To form a durable compact in a direct-compression tableting process, you must physically compress, under relatively high pressure, a homogenized blend of powders, including any active pharmaceutical ingredients (APIs) and any excipients necessary to ... read more
How Proposed EU Microplastics Legislation Could Impact the Pharma Industry
July 18, 2019
Concern about microplastics has been growing for some time, particularly in Europe. Historically, microplastics contamination of the marine environment has been attributed to factors such as large plastic wastes, scrubbing agents in toiletries, tire ... read more
Continuous Manufacturing: Excipients and Continuous Manufacturing
July 18, 2019
Continuous manufacturing of pharmaceutical finished products is now a reality. At this time, pharmaceutical companies are using continuous processes to manufacture four drug products licensed in the US and Europe. They are all solid oral dosage forms... read more
Current Discussions in Europe Regarding Titanium Dioxide Safety
July 18, 2019
Titanium dioxide (TiO2) has safely been used as a pigment in thousands of food and drug products all over the world for more than fifty years. Known in Europe and many other parts of the world as E171, TiO2 is commonly used in solid oral dosage forms... read more
Eye on Excipients: Softgel Capsule Formulation
April 11, 2019
Soft gelatin capsules (softgels) are an important dosage form option for pharmaceutical manufacturers because many patients prefer them over other solid oral dosage forms and perceive them as easy to swallow, which leads to improved patient ... read more
Eye on Excipients: Tableting Performance of Vitamin B2 and C Minitablets Using Lactose-Based Excipients
March 14, 2019
Mini-tablet use continues to grow as an accepted option for small-volume, high-value products, especially for specific patient populations. Mini-tablet applications, as either single- or multi-tablet units, allow for fixed-dose combinations and dose ... read more
Eye on Excipients: Targeting Gluten Sensitivity in Pharmaceuticals
January 10, 2019
Americans with gluten sensitivities have shown increased concern over the years regarding the presence of gluten in foods. Recently, the possibility of gluten in oral medications has been raised as a concern for gluten-sensitive patients. Gluten ... read more
Eye on Excipients: Using GMP Programs to Ensure Suppliers Deliver Quality Products
October 12, 2018
Historically, in order to meet pharmaceutical GMP expectations, excipient manufacturers have relied on the International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group’s (PQG’s) Joint IPEC-PQG Good Manufacturing Practices ... read more
Eye on Excipients: How Moisture Content Affects Excipient Behavior
September 14, 2018
The moisture content of excipients plays an important role in the physical and chemical properties of pharmaceutical products. The characteristics of the excipients for a particular dosage of a formulation depend on their moisture sorption behavior, ... read more
Formulation: Using API Powder in a Bottle or Capsule for Clinical Phase I Studies
July 12, 2018
Sometimes simple dosing with API powder in a bottle or capsule for a clinical Phase I study can be acceptable, and it may be quicker to use API powder in either a capsule or a bottle than to develop a formulation. However, use of such an approach is ... read more
Setting USP–NF Compendial Specifications in a Complex Supply Chain
July 12, 2018
With today’s global pharmaceutical supply chain, setting United States Pharmacopeia–National Formulary (USP– NF) compendial specifications for excipients is becoming increasingly complicated. This is due in part to the vast number of ingredients used... read more
Eye on Excipients: Formulating for Lactose Intolerance
May 10, 2018
Cetirizine dihydrochloride is a second-generation antihistamine that is used to treat hay fever, allergies, angioedema, and urticaria (hives). As an H1 antagonist, cetirizine relieves the symptoms of allergic reactions by temporarily blocking the ... read more
Eye on Excipients: Using Isomalt as a Carrier for Liquid APIs
April 12, 2018
Many active pharmaceutical ingredients (APIs) can be formulated into either liquid or solid oral dosage forms. A major advantage of liquid dosage forms is that the API is already dissolved and generally absorbs more quickly in vivo. Solid dosage ... read more