Pharma Blog
Potential Sources of Elemental Impurities
In considering the production of a drug product, there are broad categories of potential sources of elemental impurities. The following diagram shows an example of typical materials, equipment and components used in the production of a drug product. Each of these sources may contribute elemental impurities to the drug product, ... Read More
Metformin Tablets | Drug Digest
Current treatment guidelines recommend initiating metformin as first line pharmacotherapy unless a contraindication or intolerability exists. Metformin consistently reduces A1C levels by 1.5% to 2.0% and FPG levels by 60 to 80 mg/dL (3.3 to 4.4 mmol/L) in drug naive patients with A1C values of approximately 9%. Metformin does not ... Read More
Marochym-200 (Trypsin & Chymotrypsin) Tablets
Composition: trypsin and chymotrypsin are oral proteolytic enzymes that hasten the repair of traumatic, surgical and orthopedic procedures. The combination of these two enzymes in this product grants it anti-inflammatory, anti-edematous, fibrinolytic, antioxidant and anti-infective properties. Mechanism of action: Trypsin and chymotrypsin resolve swelling by exerting proteolytic action on wounds. ... Read More
DAYVIGO (Lemborexant) for Insomnia
DAYVIGO (lemborexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Lemborexant is a competitive antagonist of both orexin receptors, OX1R and OX2R, with a higher affinity for OX2R. It belongs to the pharmacologic class of orexin receptor antagonists. The orexin neuropeptide signaling ... Read More
SEROQUEL (Quetiapine Fumarate) | Antipsychotic Agent
Indications: Notes: Serious Warnings and Precautions: Monitoring and Tests: Others: Precautions: SEROQUEL can cause serious side effects including: Note: SEROQUEL is not a cure, but it can help manage symptoms. The following may interact with SEROQUEL: Usual dose: SchizophreniaStarting dose is 25 mg, twice daily. The recommended dose range is ... Read More
Adverse Drug Reaction (ADR)
Health Canada: Adverse reactions are undesirable effects to health products (including drugs, medical devices and natural health products). WHO: any noxious and unintended response to a medicinal product. Why are ADRs so important? Common: Expensive: Serious: Often preventable. Risk factors for the development of an ADR include: Use a systematic ... Read More
Antigens and Immunoglobulins
An antigen is any foreign substance, of whatever origin, that is capable of initiating the production of a specific blood protein called an immunoglobulin (e.g., Ig) that will act against it. The Igs so formed will react specifically with that particular antigen, neutralizing its biological effect. Thus antigens are sometimes ... Read More
Effects of pKa on the Biological Properties of Ionizable Drugs
Acidic drugs (e.g. aspirin) are generally more highly bound to plasma albumin, giving a lower volume of distribution, i.e. they tend to stay in the plasma rather than distribute to the tissues. Basic drugs (including many CNS-acting agents such as phenothiazines) are theoretically more prone to binding to acid glycoprotein, ... Read More
Asthma Problem | Symptoms and Risk Factors
Asthma inflammation is primarily due to eosinophil activity. The incidence of asthma in adults and the elderly is approximately equal. Asthma develops in a person with a genetic predisposition to asthma who is exposed to an environmental trigger. Asthma inflammation is associated with narrowing of the airway lumen and loss ... Read More
Explanation of FDA Designations
Navigating the complex landscape of clinical trials can be overwhelming, especially when it comes to understanding the various designations put forth by the U.S. Food and Drug Administration (FDA). Here’s a breakdown of some crucial designations: Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies ... Read More
EU and US GMPs | Understanding the Similarities and Differences
Similarities 1) cover a wide range of products, including RX drugs, OTCs, biologics, & medical devices. Regulations apply to all stages of manufacturing, from raw material sourcing to the final packaging and distribution. 2) require manufacturers to provide adequate training to their employees. 3) prescribe certain standards for facility design ... Read More