Taste Masking in Oral liquids
Oral liquids such as syrups and suspensions are the preferred dosage form for pediatric and geriatric patients due to their ease of administration. Swallowing a tablet can be difficult for an infant or an elderly person and injectables usually require a qualified person to administer the drug. Patient compliance in both these drastically decreases if […]
Formulating Fixed-Dose Combination (FDC) Drugs: Innovation through bilayer tablet technology
Bilayer tablets consist of two or more different layers compressed together to form a single tablet. Bilayer tablets are gaining popularity due to their ability to administer multiple active ingredients in one single dosage form. Patients prefer a simple dosing regimen rather than taking multiple different pills throughout the day. Bilayer tablets can help in […]
What is Freeze thaw (Thermal cycling) study?
A freeze-thaw study is a type of stress test performed on liquid formulations to evaluate how finished dosage forms react to repeated cycles of freezing and thawing. For example, when pharmaceutical suspensions formulations or emulsions freeze, they lose their structural characteristics that maintain their properties. Upon thawing, the drug substance may not redisperse properly or may […]
What is In-Use Stability?
An in-use stability study is performed to evaluate the chemical, physical, microbiological, and functional integrity of a pharmaceutical product after it has been opened or used but before it expires. This test is used to establish the shelf life and storage condition recommendations for pharmaceutical products after the primary packaging is opened. For example, oral […]
Does your dosage form need to be sterile? Key differences between sterile and non-sterile dosage forms
Whether a dosage form must be sterile prior to administration depends on its route of administration. Parenteral products such as injectable formulations, ophthalmic formulations, otic formulations, and aqueous inhalation products must be sterile prior to use. Oral solid dosage (OSD) and oral liquids, topical, vaginal and anal suppositories on the other hand need not be […]
Overcoming Key Challenges in Developing Fixed-Dose Combination Tablets
Fixed dose combination products are dosage forms containing two or more active pharmaceutical ingredients. Including more than one active ingredient in the same dosage form has shown to increase the effectiveness of treatment for infective diseases such as HIV and tuberculosis and also chronic conditions such as blood pressure and diabetes, where patient compliance is […]
Why CMC Experts Are Crucial for Successful Drug Development
The acronym CMC stands for Chemistry, Manufacturing, and Controls and is widely used in the pharmaceutical industry and by regulatory bodies including the US FDA. The discipline of CMC includes formulation development, drug substance and drug product manufacturing, pharmaceutical analytical testing, and the overall control strategy used to ensure quality and regulatory compliance of pharmaceutical […]
Stability Testing for Pharmaceutical Drug Products
Establishing shelf life for medicines is a requirement prior to commercializing medicine or initiating clinical trials. Requirements vary for approved pharmaceutical products, compounded medicine, or dietary supplements. Stability testing is performed on pharmaceutical products during drug development and through the life of the product to establish and verify the shelf life of the product. Packaged […]
What is an IND?
An IND is an Investigational New Drug Application that is required by a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to perform human clinical studies for investigational drug or biological product. This is federally mandated, and the requirements are set forth in 21 CFR Part 312. Why are INDs […]
CDMO vs CMO vs CRO: Key Differences
In the pharmaceutical industry, CROs refer to contract research organizations that provide clinical trial services and non-clinical toxicology services to clients. On the other hand, CMOs and CDMOs refer to Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations that primarily provide drug manufacturing and drug development services. For small or mid-sized pharma companies looking […]