What is a Compounding Pharmacy and How Can It Help You?
A compounding pharmacy is a specialized type of pharmacy that creates customized medications tailored to meet the unique needs of individual patients. Unlike traditional pharmacies that dispense mass-produced drugs, compounding pharmacies mix ingredients in precise formulations as prescribed by doctors. This personalized approach allows for adjustments in dosage strength, routes of administration, alternative delivery methods, […]
Chewable Tablets: A Guide to Formulation and Development
Chewable tablets are solid oral dosage forms designed to be chewed and swallowed rather than taken whole. They are particularly beneficial for children and those who have difficulty swallowing large tablets. These dosage forms are palatable and conveniently deliver the active ingredients found in vitamins, antibiotics, and analgesics. This guide explores their formulation and development […]
Oral Liquids – A Comprehensive Guide
Oral liquids are an essential part of modern healthcare; they offer patients a convenient way to take their medications. These pharmaceutical formulations disperse active ingredients through a liquid medium and come in various forms, such as suspensions, solutions, and syrups. They are easy to administer, making them an effective alternative for patients who struggle with […]
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 […]
Vici Health Sciences Expands Capabilities for Phase III and Commercial Manufacturing
Vici Health Sciences, a leader in pharmaceutical development and regulatory services, is proud to announce significant expansions to its service offerings in the Contract Development and Manufacturing Organization (CDMO) space. These new capabilities include Phase III clinical batch manufacturing and commercial product manufacturing, solidifying Vici’s position as a full-service CDMO. Comprehensive Solutions in Maryland With […]
Gels, Creams, Lotions, and Ointments: Key Benefits and Differences
Semi-solid dosage forms are a class of pharmaceutical formulations that exist in a state between solid and liquid, exhibiting characteristics of both. These dosage forms are widely used in various applications, particularly in topical and transdermal drug delivery. Semi-solid dosage forms, such as gels, creams, lotions and ointments, are topical formulations designed for application to […]
505(b)(1) vs 505(b)(2): Understanding the Key Differences in FDA Drug Approval Processes
The 505(b)(1) pathway is typically used for new drugs with active ingredients that the FDA has not previously approved. This pathway requires a full New Drug Application (NDA) supported by detailed safety and efficacy data from extensive preclinical and clinical trials conducted by or on behalf of the applicant. In contrast, the 505(b)(2) pathway allows […]
Tablet Defects and How to Overcome Them in Manufacturing
Oral solid dose formulations, like tablets and capsules, are the most popular dosage forms for pharmaceutical drugs in the US due to their high medication compliance amongst patients and low manufacturing cost. A bottle of tablets for a monthly prescription can sometimes be manufactured for as low as five dollars, a cost virtually impossible to […]
Understanding Bioequivalence in Generic Drug Approval
Well over 80% of medicine prescribed in the US by volume are generics. Generic substitution saves the US healthcare sector billions of dollars and makes many medicines affordable to patients. Per the US FDA, even drugs that contain the same active ingredients at the same strength utilizing the same route of administration are not considered […]
Integrating cGMP in Clinical Manufacturing
Quality and safety are of utmost importance, among other critical factors, when developing a new drug. But clinical and analytical departments sometimes struggle to decide at which phase cGMP should be incorporated. What is cGMP? The acronym cGMP stands for Current Good Manufacturing Practices. These are regulations that are enforced by the FDA to ensure […]