Pharma Digests
Formulation Development Strategy for BCS Class IV Molecules
For a Class IV drug (low solubility and low permeability) in the Biopharmaceutics Classification System (BCS), formulation development needs a strategic approach to address these limitations. Here’s how this information can be leveraged: Enhancing Solubility: Solubility-Enhancing Techniques: Use solubilizers, surfactants, or co-solvents in the formulation to improve the drug’s solubility. ... Read More
Clinical Trials with Decentralized Elements
The U.S. Food and Drug Administration (FDA) issued final guidance titled “Conducting Clinical Trials with Decentralized Elements.” This guidance provides recommendations for sponsors, investigators, and other stakeholders on implementing decentralized elements in clinical trials. A decentralized clinical trial (DCT) is defined as a trial where trial-related activities occur outside traditional ... Read More
Whether to Submit an ANDA or 505(b)(2) Application
(1) A “stand-alone NDA” is an application submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act that contains full reports of investigations of safety and effectiveness that were conducted by or for the applicant or for which the applicant has a right of reference or use. ... Read More
Types of Drug Antagonism
The several types of antagonism can be classified as follows: Chemical Antagonism Chemical antagonism involves a direct chemical interaction between the agonist and antagonist in such a way as to render the agonist pharmacologically inactive. A good example is the use of chelating agents to assist in the biological inactivation ... Read More
Factors Affecting Rate of Gastrointestinal Absorption
In addition to the lipid–water partition coefficient of drugs, local blood flow, and intestinal surface area, other factors may affect absorption from the gastrointestinal tract. Gastric Emptying Time The rate of gastric emptying markedly influences the rate at which drugs are absorbed, whether they are acids, bases, or neutral substances. ... Read More
Absorption of Drugs from Alimentary Tract
Oral Cavity and Sublingual Absorption In contrast to absorption from the stomach and intestine, drugs absorbed from the oral cavity enter the general circulation directly. Although the surface area of the oral cavity is small, absorption can be rapid if the drug has a high lipid–water partition coefficient and therefore ... Read More
Types of Drug Receptor Binding
Biological receptors are capable of combining with drugs in a number of ways, and the forces that attract the drug to its receptor must be sufficiently strong and long-lasting to permit the initiation of the sequence of events that ends with the biological response. Those forces are chemical bonds, and ... Read More
Prednisolone | Drug Digest
Prednisolone is a synthetic glucocorticoid, which works by mimicking the effects of cortisol, a naturally occurring hormone produced by the adrenal glands. It acts on the glucocorticoid receptor, affecting various cellular processes, including: Reducing inflammation by inhibiting the release of inflammatory mediators such as prostaglandins and leukotrienes. Suppressing the immune ... Read More
VagiSense | A Non-Prescription Vaginal Infection Screening Test
According to a study, about 66% of women who self-diagnosed a vaginal yeast infection were wrong. VagiSense® is a non-prescription home vaginal infection screening test that helps identify if vaginal symptoms are more likely caused by a bacterial or parasitic infection to know what steps to take next. It’s a ... Read More
Pulmonary Embolism | A Life-Threatening Condition
As a professional pharmacist, it’s critical to shed light on Pulmonary Embolism (PE), a serious condition that can be life-threatening if not promptly treated. What is Pulmonary Embolism? PE occurs when a blood clot travels to the lungs, blocking one or more pulmonary arteries. This blockage can severely impair lung ... Read More
FDA Non-Clinical Study Requirements for IND
Non-clinical studies are essential for assessing the safety and biological activity of an investigational drug before it is tested in humans. Here are the key aspects and requirements for non-clinical studies in an IND application: Pharmacology and Toxicology Information Non-clinical studies primarily focus on pharmacology and toxicology to evaluate the ... Read More