Erythromycin stearate tablets quality assurance assessment

Wondie Birhanu et al. BoxAddis Ababa, Ethiopia Keywords: Identity, weight uniformity, disintegration, dissolution and Correspondence to Author: It also failed to fulfill the tolerance limits University, P.

Erythromycin stearate tablets quality assurance assessment

Adverse effects[ edit ] Gastrointestinal disturbances, such as diarrheanauseaabdominal painand vomitingare very common because erythromycin is a motilin agonist. It may be useful in treating gastroparesis due to this promotility effect. Intravenous erythromycin may also be used in endoscopy as an adjunct to clear gastric contents.

More serious side effects include arrhythmia with prolonged QT intervals including torsades de pointesand reversible deafness. Allergic reactions range from urticaria to anaphylaxis. CholestasisStevens—Johnson syndromeand toxic epidermal necrolysis are some other rare side effects that may occur.

Studies have shown evidence both for and against the association of pyloric stenosis and exposure to erythromycin prenatally and postnatally. Some evidence suggests similar hepatotoxicity in other populations.

Erythromycin is an inhibitor of the cytochrome P system, which means it can have a rapid effect on levels of other drugs metabolised by this system, e.

Erythromycin stearate tablets quality assurance assessment

If other CYP3A substrates — drugs that are broken down by CYP3A — such as simvastatin Zocorlovastatin Mevacoror atorvastatin Lipitor —are taken concomitantly with erythromycin, levels of the substrates increase, often causing adverse effects. A noted drug interaction involves erythromycin and simvastatin, resulting in increased simvastatin levels and the potential for rhabdomyolysis.

Another group of CYP3A4 substrates are drugs used for migraine such as ergotamine and dihydroergotamine ; their adverse effects may be more pronounced if erythromycin is associated.

Other examples include terfenadine Seldane, Seldane-Dastemizole Hismanalcisapride Propulsid, withdrawn in many countries for prolonging the QT time and pimozide Orap. Theophyllinewhich is used mostly in asthma, is also contraindicated.

Erythromycin and doxycycline can have a synergistic effect when combined and kill bacteria E. This synergistic relationship is only temporary. By binding to the 50s subunit of the bacterial rRNA complex, protein synthesis and subsequent structure and function processes critical for life or replication are inhibited.

Without this translocation, the A site remains occupied, thus the addition of an incoming tRNA and its attached amino acid to the nascent polypeptide chain is inhibited. This interferes with the production of functionally useful proteins, which is the basis of this antimicrobial action.

Erythromycin increases gut motility by binding to Motillin, thus it is a Motillin receptor agonist in addition to its antimicrobial properties. Pharmacokinetics[ edit ] Erythromycin is easily inactivated by gastric acid; therefore, all orally administered formulations are given as either enteric-coated or more-stable salts or esterssuch as erythromycin ethylsuccinate.

Erythromycin is very rapidly absorbed, and diffuses into most tissues and phagocytes. Due to the high concentration in phagocytes, erythromycin is actively transported to the site of infection, where, during active phagocytosislarge concentrations of erythromycin are released.

Erythromycin levels peak in the serum 4 hours after dosing; ethylsuccinate peaks 0. The American Association of Pediatrics determined erythromycin is safe to take while breastfeeding. Each of these compounds can be present in varying amounts and can differ by lot. Erythromycin A has been found to have the most antibacterial activity, followed by erythromycin B.

Erythromycins C and D are about half as active as erythromycin A. Synthesis[ edit ] Over the three decades after the discovery of erythromycin A and its activity as an antimicrobial, many attempts were made to synthesize it in the laboratory.

· For construction of control strategy for the final manufacturing process and quality assurance of Sakura Tablet, the following approaches were employed. 1. Setting of Target Product Profile and early phase risk assessment 2. Risk assessment of composition and manufacturing process of the drug product  · done on these two products (namely Rycin® and Erythromycin mg) in order to draw a more definite conclusion.

Keyword: Stearic acid, formulation, physicochemical, friability Journal Of Harmonized Research in Pharmacy 4(2), , QUALITY ASSURANCE ASSESSMENT OF SOME COMMERCIALLY AVAILABLE ERYTHROMYCIN STEARATE  · Quality assurance in pharmaceutical supply systems 1: Regulatory elements: Technical elements: 3.

Pre-marketing quality assessment: Drug notification, authorization and registration: Drug nomenclature: 4. Drug quality surveillance during marketing erythromycin stearate. capsule, mg of erythromycin?

+b +b: powder for Erythromycin is an antibiotic useful for the treatment of a number of bacterial infections. This includes respiratory tract infections, skin infections, chlamydia infections, pelvic inflammatory disease, and syphilis.

It may also be used during pregnancy to prevent Group B streptococcal infection in the newborn. Erythromycin may be used to improve delayed stomach emptying.

Detailed Images Packing & Delivery 10 tablets per blister, 10 blisters per carton. Ad. Factory supply Antibiotic api erythromycin Stearate, erythromycin thiocyanate 99% powder.

US $ cosmetics, etc. The company has perfect enterprise quality assurance system, implementation of strict quality control standards. Veterinary Drug Raw In this study, an attempt was made to assess the physicochemical equivalence of four brands of Erythromycin stearate tablets marketed in Addis

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