Project Abstract

<p> The active drug content and weight uniformity of five brands (A – E) of Amoxicillin Trihydrate<br>capsules in Nsukka open drug market were evaluated to ascertain their quality assurance<br>using UV visible spectroscopy and gravimetry. This study has shown that all the brands<br>analyzed showed significant variations with respect to active drug content determination for the<br>three brands B, D and E. Using United State Pharmacopoeia (USP) and British Pharmacopoeia<br>(BP) specifications of 90 – 110 %, the values obtained were B – (413.525 mg), D – (440.325<br>mg), E – (414.100 mg). These values were within the general drug acceptance limit of 80 – 110<br>% but failed the antibiotic amoxicillin trihydrates USP and BP specifications with acceptable<br>limit of 90 – 110 % determined at 266 nm. The percentage mean content of all the brands (A –<br>E) were 77.64, 82.80, 74.24, 88.07 and 82.82. All the brands passed the weight uniformity test<br>with coefficient of variation CV value range of ± 0 – 5 % for capsules more than 250 mg<br>according to USP and BP specifications. However, with the result obtained, the<br>consequences are that it poses a serious threat to the health of the entire people of West<br>Africa sub regions that depend on these drugs for therapeutical response. As all the drugs<br>assayed were below the acceptance limit requirement of antibiotic amoxicillin trihydrate<br>and thus, can lead to serious health implications such as drug resistance, cardiac failure,<br>etc. Drug regulatory bodies should be at alert and they should conduct strict routine check<br>on all the NAFDAC satisfied companies as all the drugs analyzed compromise their<br>quality because of profit reasons. <br></p>

Project Overview

<p> 1.0 INTRODUCTION<br>1.1 ANTIBIOTICS<br>An antibiotic is a compound or substance that kills or slows down the growth of<br>bacteria [1]. The term is often used synonymously with the term antibacterial; however,<br>with increased knowledge of the causative agents of various infectious diseases,<br>antibiotic(s) has come to denote a broader range of antimicrobial compounds, including<br>antifungal and other compounds [2]. It can be loosely defined as the variety of substances<br>derived from bacterial sources (microorganisms) that control the growth of or kill other<br>bacteria. However, synthetic antibiotics, usually chemically related to natural antibiotics,<br>have since been produced that accomplish comparable tasks.<br>1.2 Modern antibiotics<br>The term “antibiotics” was coined by Selman Waksman in 1942 to describe any<br>substance produced by a micro-organism that is antagonistic to the growth of other<br>micro-organism in high dilution [3]. This definition excluded substances that kill bacteria,<br>but are not produced by microorganisms (such as gastric juices and hydrogen peroxide).<br>It also excluded synthetic antibacterial compounds such as the sulphonamides. Many<br>antibiotics are relatively small molecules with a molecular weight less than 2000 atomic<br>mass units [3].With advances in medicinal chemistry, most antibiotics are now semi<br>synthetic modified chemically form of the original compounds found in nature,[4] as is the<br>case with beta-Lactams (which include the penicillins, produced by fungi in the genus<br>penicillium, the cephalosporins, and carbapenems). Some antibiotics are still produced<br>and isolated from living organisms, such as the amino glycosides and others have been<br>created through purely synthetic means, the sulphonamides, the quinolones, and the<br>oxazolidinones[4]. In addition to this origin-based classification into natural, semi<br>synthetic, and synthetic, antibiotics may be divided into two broad groups according to<br>2<br>their effect on micro-organisms. Those that kill bacteria are bactericidal agents, whereas<br>antibiotics are commonly classified based on their mechanism of action, chemical<br>structure, or spectrum of activity [4]. Most antibiotics target bacterial functions or growth<br>processes. Antibiotics that target the bacterial cell wall (penicillin, cephalosporins), or<br>cell membrane (polymixins), or interfere with essential bacterial enzymes (quinolones,<br>sulphonamides) are usually bactericidal in nature. Those that target protein synthesis,<br>such as the amino glycosides, macrolides and tetracyclines are usually bacteriostatic.<br>Further categorisation is based on their target specificity.<br>Narrow spectrum” antibiotics target particular types of bacteria, such as Gramnegative<br>or Gram-positive bacteria, where as broad spectrum antibiotics affects a wide<br>range of bacteria. In the last few years, three new classes of antibiotics have been brought<br>into clinical use. This follows a 40-year hiatus in discovering new classes of antibiotics<br>compounds. These new antibiotics are of the following three classes; cyclic lipopeptides<br>(daptomycin), glyclycyclines (tigecyclines), and oxazolidinones (linezolid).Tigecyclines<br>is a broad spectrum antibiotics, where as the other two are used for Gram-positive<br>infections. These developments show promise as a means to counteract the bacterial<br>resistance to existing antibiotics.<br>1.3 FAKE DRUGS<br>Fake drugs otherwise called ‘counterfeit drugs’ can be defined as drug that are unfit for<br>usage and human consumption and therefore constitute hazard to good and sound health.<br>Considering the above definition, the evil effect of fake drugs can be better understood by<br>looking back to what the situation was several years back, before the country got to her<br>present situation. The situation could be said to have gone bad many years back when our<br>hospitals changed from health institutions of excellence to mere consulting clinics<br>occasioned by non-availability of drugs. As a result of this problem, dubious and<br>unpatriotic persons came in with fake drugs which they supplied to the hospitals. Added<br>to these problems are the activities of smugglers who perhaps because of the porous<br>3<br>nature of the Nigerian boarders and the connivance of some law enforcement agents,<br>bring fake drugs into the country [5].<br>Faking of drugs is a global public health problem, because the effects can be felt<br>from both the country of manufacture to the recipient countries. Hence, national measures<br>for combating fake drugs in a country might be insufficient because of the advanced<br>sophistications of those who manufacture and sell them [5]. Nigeria is not an exception in<br>the problems of fake drugs till date. Some people still prefer to self medicate when they<br>are ill, and often time the drugs are bought from unlicensed drug vendors, whose drug<br>quality is not sure. Through the past two decades in Nigeria, the problem of fake drugs<br>has been a very big issue. In addition, fake drugs proved a major factor in contributing to<br>high death rates. Over 50 children died in 1989 as a result of a formulation error in a drug<br>[5]. Such problems led to the establishment of National Agency for Food Drug<br>Administration and Control (NAFDAC), which would help create a fake-drug-free<br>environment [5]. The intent was to ensure effective registration of good quality drugs that<br>are inexpensive in Nigeria. Since the inception of NAFDAC in April 2001, the<br>commission has worked hard in combating the problems of sale of fake drugs, but yet to<br>no avail [5]. Questions are, ‘why does Nigeria still have in existence open drug markets?<br>Why do Nigerians in drug business breech the stipulated drug laws and still get<br>away with it and continue with their business, committing mass murder and smiling to<br>their banks? How long do we fight the battle of fake drug even with the threats on our<br>lives who want to preserve the health of the Nation? The consistent raids by NAFDAC on<br>fake drug dealers who contravene the applicable laws and regulations, have helped in<br>clamping down on the illegal drug traders but when things seem as if it’s getting better,<br>these illegal drug sellers begin to emerge from their hideouts [5]. I continue to wonder,<br>why? Could it be that the agency is not doing enough to stop the evil activities, or could<br>the problem be from the drug sellers themselves? The tragic irony is that the problems of<br>fake drug have refused to go away from the shores of Nigeria.<br>4<br>1.4 DRUG REGULATORY AND ENFORCEMENT AGENCY<br>The role of any drug regulatory agency is the protection and promotion of public health.<br>The enforcement directorate arm of NAFDAC established under the provisions of the<br>counterfeit and fake drugs (miscellaneous provision) act is charged with the<br>responsibility of enforcing the provisions of the counterfeit and fake drug decree, which<br>includes:<br>Ø Conducting surveillance on companies and persons suspected to be violating<br>NAFDAC regulations and carrying out investigations on such persons and<br>companies.<br>Ø Paying unscheduled visits to all ports of entry and border posts and<br>interrogation of suspects.<br>Ø Sampling of NAFDAC regulated products for laboratory analysis and<br>compilation of case files.<br>Ø Raiding of drug hawkers and destruction of fake and spurious regulated<br>products.<br>Ø Coordination of activities of state task force.<br>Ø The establishment of the task force in Nigeria was seen as a welcome<br>development for the fight against fake drugs.<br>1.5 DRUG PROFESSIONALS<br>The main professional organization of pharmacist in Nigeria is the Pharmaceutical<br>Society of Nigeria (PSN). The organization was established in 1927, with membership<br>over 7000 pharmacists [6]. Its main functions are to determine the skill and knowledge<br>that is required of anyone who seeks to be registered as a member of the pharmacy<br>profession, preparation and review of the code of conduct, regulate and control the<br>practice of the pharmacy profession. PSN also has a panel that investigates and<br>disciplines erring pharmacists.<br>According to the PSN president, the main sources of fake drugs in Nigeria are<br>India, China, Pakistan, Egypt and Indonesia [7]. The influx of fake drugs is quite<br>5<br>worrisome to the health experts. It is difficult to get reliable data on mortality or<br>morbidity caused due to the consumption of fake drug in Nigeria. In 1987, an increased<br>number of fake drugs were noticed in some market places, even in some pharmacy<br>outlets [7]. Chemical test showed that they contain smaller amount of the active ingredient<br>of the drugs. Some pharmaceutical companies felt it was due to laxity of inspection that<br>contributes to the successful faking. On 31 October 1987, the Pharmaceutical Society of<br>Nigeria (PSN) discussed the implication of fake drug manufacturing, marketing as well<br>as possible remedies; they identified some major drugs that are often faked viz;<br>antibiotics, antifungal agents, antihypertensive, malaria medicines, bronchodilators and<br>hormonal preparations. They related the problem of drug faking to exchange control<br>situation that causes scarcity and high price for drugs and that government can help<br>reduce the problems through provision of essential drugs at reasonable price to the people<br>which will in turn make fake drugs low priced and less attractive [8].The effect from fake<br>drug consumption usually goes unnoticed, except in cases where it results to mass death.<br>These problems made the PSN as a body to pressure Nigerian government in taking<br>definite step towards the control of fake drug. Hence, the promulgating of the counterfeit<br>and fake drug decree No. 21 of 1988 that prohibits the sale and distribution of fake drugs<br>in open markets and created penalties for anyone who breaches the law [6]. In United<br>States of America, pharmacists are allowed to work with foreign governments,<br>international regulatory bodies as well as law enforcement agencies. This collaboration<br>enables them to detect and combat counterfeiting [9]. In Cuba, almost all pharmaceutical<br>operations are owned and managed by the government who determines how drugs are<br>regulated and the members of their drug professional groups can get involved in drug<br>regulation by joining the advisory committee [10].<br>1.6 INFORMAL DRUG SELLERS<br>Informal drug sellers are people that sell drugs in an unregulated manner without<br>professional consultation and with limited knowledge of pharmacy. Their main aim in<br>drug business is the profit they make even when they are aware of fake drug proliferation.<br>6<br>They can store and handle drugs in inappropriate ways that can endanger the drug<br>potency [11].<br>Informal drug sellers can be found in shops, kiosks, open markets, general stores<br>etc, and can operate as itinerant hawkers. Just like any other business, their existence is<br>maintained in accordance to consumer demands for easy accessibility, convenience and<br>affordable supplies. They can be very friendly, approachable and promising to their<br>customers. Their attraction to those that patronizes them is that they have cheaper<br>products when compared to the formal Outlets and their products can be given on credit<br>because they source their products from cheaper sources. Most of these drug sellers are<br>less knowledgeable about the doses of drug appropriate for a particular illness; their<br>prescription could be higher or lower than the correct dosage because their major aim is<br>more on profit making and meeting up with competition from other sellers [11].<br>1.7 Dangers associated with purchasing from informal drug sellers<br>Consumers/buyers are exposed to dangers from hazardous drugs because they are<br>entrapped in the web of fake drugs without respite and any one can be a victim. Many<br>drugs are offered for sale in Nigeria without expiration dates and can be bought and sold<br>over the counter or by hawkers selling alongside newspaper vendors (personal<br>observation). A man who is sick can walk to any drug store and come out with<br>prescriptions loaded with drugs. In some cases, smooth talking drug peddlers in public<br>buses save such a man the walk to a drug outlet. Consumers on the other hand may not<br>know the quality of products they are purchasing [11]. The reasons why consumers prefer<br>to patronize such outlets include geographical accessibility,<br>Shorter waiting times, longer opening hours, greater confidentiality, more personable<br>social interaction, ease of seeking advice, lower cost, flexible pricing policies and no<br>separate fee charged for advice. However, one of the problems associated with selfmedication<br>with drugs from these sellers is that in most cases, neither the drug seller nor<br>the consumer is aware of the correct dosage and duration of treatment [12].<br>7<br>1.8 AIMS AND OBJECTIVES<br>(a.) To assay some brands of amoxicillin trihydrate in the Nigerian market with a view<br>to ascertain the quality assurance using official standards for quality drug samples.<br>(b.) To determine the drug claim of active ingredient of the brands of amoxicillin<br>trihydrate with strength 500 mg.<br>8 <br></p>