The adequacy with which a formulated medicine is protected from spoilage by the use of a preservative cannot easily be predicted from a study of the activity of the preservative in simple aqueous solutions. A person with limited knowledge of pharmaceutical microbiology might, for example, expect that it would be possible to confirm that a …
Preservative interactions with formulation components and containers Read More »
The antimicrobial chemicals commonly used as preservatives in medicines are will be a stand alone article. The properties that are normally required in such a preservative include the following: a broad spectrum of antimicrobial activity covering Gram-positive and Gram-negative bacteria, yeasts and moulds, and no vulnerability to resistance development; low toxicity for humans, enabling it …
Whilst product contamination during use is largely outside the manufacturer’s control, there are many steps that can be taken to minimize contamination while the product is made, both by restricting the entry of new organisms into it and by limiting the opportunities for growth of organisms that are unavoidably present at the start, such as …
Control of contamination and spoilage during manufacture Read More »
In addition to water activity, which was considered earlier in this chapter, factors influencing the rate and extent of growth of a contaminant within a pharmaceutical raw material or manufactured medicine include: nutrient availability; temperature; pH; redox potential; and the presence and concentration of antimicrobial chemicals. Microorganisms differ enormously in their metabolic capabilities. Some, such …
Factors influencing the growth of spoilage organisms Read More »
Microbial contamination of medicines arises from three principal sources: the raw materials, including water, from which the product is manufactured; the manufacturing environment, including thenatmosphere, equipment and work surfaces; and manufacturing personnel. The relative contributions of these three sources vary depending on the type of product in question. It is a known fact that raw …
Sources and types of contaminating organisms in pharmaceuticals Read More »
Spoilage, in the sense of detectable physical or chemical change within a pharmaceutical product, nearly always follows growth and reproduction of the contaminating organisms. The pharmacopoeial and regulatory limits for the maximum permissible numbers of microorganisms in manufactured products or raw materials are typically not more than 100–1000 colony-forming units per millilitre or gram depending …
The need to protect foods against microbial spoilage is well appreciated because microbial growth results in obvious signs of deterioration. However, there is a much lower level of awareness among members of the general public of the need to similarly protect cosmetics, toiletries and medicines. Although most medicines present a less favourable environment for microbial …
The need to protect medicines against microbial spoilage Read More »
Congestive cardiac failure Congestive cardiac failure (CCF) is the combined failure of both the left and right sides of the heart. The incidence of cardiac failure in the UK is between 1 and 5 per 1000 per year, and doubles for each decade of life after the age of 45. CCF occurs when the cardiac …
Basic concepts The heart is a pump which together with the vascular system supplies the tissues with blood containing oxygen and nutrients, and removes waste products. The flow of blood around the body is as follows: Deoxygenated blood from body tissues reaches the right atrium through the systemic veins (the superior and inferior venae cavae). Blood …
Drug history A patient’s drug history is a crucial component of the clerking process, as drug effects account for a significant proportion of hospital admissions, and potential drug interactions and adverse events are crucial to foresee. A complete list of the names and doses of prescribed drugs taken by the patient (noting the proprietary and …