8. Quality, safety and efficacy of drugs Safety and efficacy of pharmaceuticals are two fundamental issues of importance in drug therapy. The safety of a drug is determined by its pharmacological and toxicological profile as well as the adverse effects caused by the impurities in bulk and dosage forms. The impurities in drugs often possess unwanted pharmacological or toxicological effects by which any benefit from their administration may be outweighed (Nageswara at el., 2003). Therefore, it is quite obvious that the products intended for human consumption must be characterized as completely as possible. The quality and safety of a drug is generally assured by monitoring and controlling the impurities effectively. Thus, the analytical activities concerning quantification of active ingredients and impurities in drugs are among the most important issues in modern pharmaceutical analysis (Nageswara at el., 2003). 9. Regulatory aspects To guarantee the quality, clinical performance, efficacy, and safety of a pharmaceutical product, specifications are fixed and approved by the competent regulatory authorities of each country in which the drug is marketed. Analytical testing ensures that these specifications are met by confirming the identity, purity, and potency of drug substances and drug products prior to their release for commercial use. To assure reliable bioavailability, drug products' performance testing is needed (Ahuja and Dong, 2005). This performance testing comes in the form of either dissolution or disintegration tests. In the UK the MHRA is an executive agency of the Department of Health that sets the standards of safety, quality and performance of drugs for human use. All licensed medicines in the UK are evaluated b... ... middle of paper ... ...e retention time under particular conditions is considered a reasonably unique identifying characteristic of a given compound and can be used to identify the compound through HPLC-MS or HPLC-DAD which are the most powerful techniques in this respect (Ahuja and Dong, 2005). The sensitivity, specificity and accuracy of HPLC-UV for the analysis of AT in drug substances or drug formulations together with impurities has been successfully validated and applied (Mohammadi et al., 2007). A good resolution for AT, and its two known impurities desfluoro-atorvastatin (DFAT), diastereomer-atorvastatin (DSAT), and other unknown impurities and formulation excipients of tablets can be obtained by adopting a simple HPLC method. The best resolution is obtained using a Luna C18 column with acetonitrile-ammonium acetate buffer and 4-tetrahydrofuran (THF) as mobile phase (Erturk at
...s the change in the temperature of both of these batches, 6°C for the pure, and 13°C for the crude. In this final sub-section of the Characterization of Aspirin, the values of absorbance were recorded. Initially, 0.0566 grams and 0.0590 grams of pure and crude Aspirin respectively were obtained and each individually placed into beakers (400 milliliter) and had 250.0 milliliters of distilled water added to them. From each beaker, a tiny amount of the just dissolved solutions was transferred to a cuvette, one cuvette for each type of aspirin. Each cuvette was placed into the ultraviolent spectroscopy mechanism which was connected to a computer and absorbance spectrum values were obtained at 298 nm (Figure 5) (0.1987 pure aspirin, and 0.9549 crude aspirin).
Craig, D. Q. (2002). Pharmaceutical Applications of Micro-Thermal Analysis. Journal of Pharmaceutical Science, 91(5), 1201-1213.
...d to mix the contents of the column. Aside from these commonalities, the instrumentation used varies greatly depending on the type of countercurrent chromatography used.
Why do consumers purchase specific drugs for various ailments, sicknesses or diseases they might have? Why do physicians prescribe certain drugs over competitive drugs that may be available to the public? Why is it that most of us can easily name specific drugs that fit the many ailments of today’s society? On the surface the answer might be as simple as good TV advertising or radio commercials or even internet adds. The truth of matter is the major pharmaceutical manufacturers own the patents on these drugs and this gives them all of the marketing budget and muscle they need to promote the drug and control the pricing. The incentives for larger pharmaceutical companies are very enticing and as a result, they don’t mind spending the time in clinical trials and patent courts to get their drugs approved. Some will even get patents on the process by which the drug is manufactured, ensuring that no competitor can steal the drug or the process. This protects their large financial investment and nearly guarantees a large return for their investors. Many consumer rights groups claim this is nothing more than legalizing monopolies for the biggest manufacturers.
Hochadel, M. (2014). Mosby's Drug Reference for Health Care Professionals (fourth edition ed.). : Elsevier.
Pharmacy is a booming field when it comes to medicine, but it certainly has controversial issues such as compounding drugs. While the practice of making drugs customized to a patient seems ethical, there are problems that come along with it. Drug compounding was the norm in the past, but over time consumers began to see issues with it. Drug compounding still occurs to this day because some patients do need medicine specifically tailored to their needs. Compounding has also been the focus of recent disasters, some of which occurred less than two years ago. Whatever side one may take on this issue, it is clear that compounding medicine will be a polarizing issue for years to come.
this is called toxicological or other product safety estimate. And some tests are used for a assort...
As we discussed above that pharmacokinetic and pharmacodynamics can be seen as two sides of the same coin in order to gain better understanding of their efficacy and safety profiles.” Generally it is possible to make fairly robust predictions of the pharmacokinetic profile in man using in vitro systems and preclinical pharmacokinetic studies. A previously published survey on the causes of failure in drug development indicated that inappropriate pharmacokinetics were a major cause such as; factors as low bioavailability due to high extraction or poor absorption characteristics, short elimination half-life leading to short duration of action and excessive variability due to genetic or environmental factors. This observation has led to an increased emphasis on pharmacokinetic input to the drug discovery process throughout the pharmaceutical industry. However, it is important to realise that this may only permit the rejection of compounds to b...
outlines the benefits and risk reported in the tested population. For a drug to be approved by
The ability to become reflective in practice has become a necessary skill for health professionals. This is to ensure that health professionals are continuing with their daily learning and improving their practice. Reflective practice plays a big part in healthcare today and is becoming increasingly noticed.
The conical vial was placed in a small beaker and allowed to cool to room temperature. The mixture was Cooled thoroughly in an ice bath for 15-20 minutes and crystals collected by vacuum filtration on a Hirsch funnel. The vial was rinsed with about 5 mL of ice water and transferred into to the Hirsch funnel and again washed with two additional 5mL portions of ice water. Crystals were dried for 5-10 minutes by allowing air to be drawn through them while they remained on the Hirsch funnel. The product was transferred to a watch glass plate and allow the crystals to dry in air. Crude acetaminophen product was weighed and set aside a small sample for a melting point determination and a color comparison after the next step. Calculation of the percentage yield of crude acetaminophen (MW = 151.2). was done and recorded in the lab notebook.
Analysis of Aspirin Tablets Aim --- To discover the percentage of acetylsalicylic acid in a sample of aspirin tablets. ----------------------------------------------------------------- In order to do this, the amount of moles that react with the sodium hydroxide must be known. This is achieved by using the method of back titration.
Stationary phase is of extreme importance in an HPLC analysis, as the chemical nature of the same and its compatibility with the analyte of interest is extremely significant for efficient separation. The most commonly used stationary phase is silica packed column which acts as a adsorbent. Each component in the sample interacts with these silica particles and gets eluted out in different time intervals. These silica columns may be of C14 or C18 type depending on the component of interest and also the columns themselves come in various dimensions each with a specific purpose of analysis.
Gusdinar T. COMPLEXOMETRIC TITRATION An application method of Inorganic Pharmaceutical Analysis [homepage on the internet] . No date. [cited 2014 Mar 20]. Available from: http://download.fa.itb.ac.id/filenya/Handout%20Kuliah/Inorganic%20Pharmaceutical%20Analysis%202008/English%20Version/05.%20COMPLEXOMETRIC%20TITRATION.pdf.
When studying for my Bachelor degree in Pharmacy, I received an interesting exposure to the basics of administration of Pharmaceutical industries which has further fueled my interest in learning the process of Approval from Food and Drug Administration and other laws that regulate Manufacturing, Marketing and advertising of Drugs, Pharmaceuticals and Health care devices to ensure that they are safe and effective. This has inspired me to opt for an MS program in this field and would also provide an intellectual, cultural, ethical understanding and awareness needed to become leaders and innovators in global society.