Ciprofloxacin is one of fluoroquinolone antibiotics and
its effective against gram positive and negative (1).
The mechanism of action of antibiotic is to inhibit bacterial
DNA gyrase topoisomerase II and topoisomerase IV which lead to interfere with
DNA transcription and replication and they prevent the DNA of bacteria from
duplicating which will lead cell poisioning and death (2). fluroquinolones has a broad spectrum activity and available in
many countries and approved treatment of many infections for examble UTI, ,
gonorrhea, and osteomyelitis, Bone infection, respiratory infection and joint
The most common side effects for people who are using
fluoroquinolone are gastrointestinal
side effects (nausea, diarrhea, vomiting)
and also CNS side effects (dizziness, headache, nervousness, seizures,
confusion, tremors,) and skin side effect (rash, urticaria, and
photosensitivity) (2). Also there are some adverse effects which are increase
in blood nitrogen urea and increase serum creatinine and also increase in liver
enzyme and jaundice. There are many brands of Ciprofloxacin in Saudi Arabia
market from different manufacturers. In this study we investigated and assessed
the Pharmaceutical quality of different brands of Ciprofloxacin 500mg tablets (Ciproquin®,
Ciflox® and Ciprogram®) that been marketed in Saudi
Arabia in order to obtain the quality of the products. The reasonable access to health care in any country of the
world is a human right and governments should do their best to ensure the
provision of a high quality health care for their people (4). The health
care system compose of several important component are staff that are
qualifired and drugs and health services (4).Drugs has roles in cure and
prevention so the have to be specialy concerned.(4) in addition they are might
be dangerous and must be used in carful and rational way (4).
Alma ata conference (WHO
and UNICEF conference) at 1978 develop principles for primary health care (PHC)
to ensure high quality and safe drug use, principle such as availability of the
Essential Drugs List (EDL) (4).
The quality of drug means that
the drug contains the claimed quantity of the
active ingredient on its label and from the dosage of one unit to the other and
it has to be free from foreign substance and to maintain it potency and
appearance of drug and availability until the use and when administrated it should has the entire
biological availability by releasing the active ingrediant (5).
Quality control is the part
of Good Manufacture Practice (GMP) that is concerned that products manufactured
or produced according to quality standards (6).
Increasing in economy lead
to expansion of pharmaceutical industry and furthermore producing many brands
of the same drug in the market (7). In many countries the drug cost account
for a large share of the total budget of the health (6).
Increasing number of
generic drug from different sources made lead prescribers and people one of
many product which are equivalent product (8). Many of them are in affordable
price but not sure about their quality (7).
However, they do not have
an effective means of monitoring the quality of generic drug products in the
market of many developing countries (8). This lead to widespread distribution
of substandard or / and counterfeit drug products (8).
Drugs must meet the efficacy
and safety and quality standerds(8). Its very
important to do physicochemical assessment of the product and in vitro to
predict the vivo availability and bioequivalent of solide oral dosage form (8). The questions of drug quality, drug cost, drug selection
and effectiveness, and proper drug utilization have become a matter of
widespread public interest (5). Pharmacist have to have a hight knowledge in
drug product quality and optimal drug utilization on an individual patient
poor quality can be as result of accident and its not intentional in the
manufacturing and thus can produce tragic consequence (9). Such as what
happened in haiti in 1995, glycerin contaminated with 24 % of diethylene glycollead to epidemic
sever toxicity and death (10). drugs can offer a simple cost effective answer
to many of health problems If the drug is affordable or available of good
quality and used properly (6).