Stability of amoxycillin and potassium clavulanate in co-amoxiclav oral suspension

Abstract

A study was carried out using high performance liquid chromatography (HPLC) to determine the chemical stability of amoxycillin and potassium clavulanate in 250/62 co-amoxyclav oral suspension (Augmentin), stored at room temperature (RT, 20 degrees C) and 8 degrees C over a period of 11 days. The suspension was judged to be acceptable if its components maintained at least 90% of their label concentrations. During the test period, the amoxycillin component was found to be more stable than the clavulanate. Amoxycillin was stable for 7 days at both temperatures. Potassium clavulanate maintained at least 90% of its initial concentration for 7 days at 8 degrees C but showed more than 40% degradation in the same time period at RT. For potassium clavulate the shelf-life, or time taken for the original concentration to drop to 90% of its value (t90) at RT was found to be 2 days.

Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs

“…Similarly, the concentration of Arthemether differs slightly from the manufacturer claim (80 mg), this variation could be attributed to the storage temperature and the difference is above the recommended standard. The results of these analysis is similar to the study carried out by Mehta et al [21] which shows that amoxicillin and potassium clavulanate (250/62 Co-amoxiclav) oral suspension stored at room temperature 20°C and 8°C over a period of 11 days showed that amoxicillin is stable for 7 days at both temperatures. Also in agreement is the work by Naidoo [22] which showed that amoxicillin suspension stored between 2°C and 8°C for 7 days showed the lowest level of degradation.…”

Oral amoxicillin and amoxicillin–clavulanic acid: properties, indications and usage

“…Mehta et al observed 90% conservation of reconstituted oral amoxicillin at 20°C for only 7 days [19], while Peace et al report only 79% conservation at 7 days at a temperature of 27-29°C [20]. Currently there are few data on the stability of oral amoxicillin tablets.…”

“…Its stability in aqueous solutions has been poorly characterized, though one recent study noted that in sodium chloride, stability was maintained for 8 hours at 4°C and for only 4 hours at 20°C. Reconstituted oral suspensions appear to be somewhat more stable; at 8°C, clavulanic acid maintains at least 90% of its initial concentration for 7 days, though at 20°C only 60% is maintained in the same time period [19], and at 27-29°C, only 55% [20].…”

Cold Chain-Free Storable Hydrogel for Infant-Friendly Oral Delivery of Amoxicillin for the Treatment of Pneumococcal Pneumonia

“…However, the lack of clean water and electricity in developing areas makes this fight highly challenging for humanitarian agencies and local/mobile healthcare workers. , For example, amoxicillin is an inexpensive and highly effective drug used against a number of pathogens, including Streptococcus pneumoniae, the most common cause of community-acquired pneumonia. , It is one of the most commonly prescribed antibiotics for children, being on the list of essential medicines recommended by World Health Organization . Amoxicillin is commercially produced as a powder and readily available in the market in a variety of drug formulations including syrups, reconstituted aqueous suspensions, capsules, chewables, and tablets. , Liquid-based formulations of amoxicillin require stringent storage conditions (i.e., refrigeration) to prevent activity loss due to degradation. − The use of nonliquid-based forms (i.e., capsules, chewables, and tablets) constitute a viable option to prevent amoxicillin degradation due to hydrolysis. , However, such options are not quite convenient for infant/toddler patients who cannot safely swallow or chew hard substances. , Thus, there is a great need for an infant/toddler-friendly formulation for patients in the low-income countries, with limited clean water and electricity.…”