5^th International Summit on GMP, GCP & Quality Control August 12-13, 2016 Toronto, Ontario, Canada

Kolawole J A, PhD, FPSN, FPCPharm, FIPAN, completed his PhD from the Ahmadu Bello University, Zaria and The Robert Gordon, University, Aberdeen, UK (1996). He is the Dean, Faculty of Pharmaceutical Sciences, University of Jos and Consultant to West African Health Organization, on development of guidelines and training manuals for, Pharmaceutical Finished Products; Pharmaceutical Raw Materials; Standard Operating Procedures for Laboratories; Bioavailability/Bioequivalent. He has more than 40 publications in international journals.

Determination and implementation of appropriate dose(s) and dosing is important for therapeutic effectiveness of medications. This study surveyed children oral medications on the Liberian pharmaceutical market for appropriate dose/dosage and delivery devices. In the qualitative work, caregivers were interviewed and surveys were conducted in pharmacies for oral medications and the quantitative phase involved the evaluation of the delivery devices. The result of the survey showed that 95.7% of caregivers followed instructions provided at the point of dispensing or as on label of product. Survey result showed that 56% of the oral medicinal products have specific direction for usage while 73% have the inscription “as directed by the physician”, either alone or in combination with specific direction for use. Medicines with delivery device as cup were 80.94% and those with teaspoons were 1.79%, while 17.28% do not have any form of delivery device. 53.11% of the medicinal products provided instruction for delivery of the medicines in “teaspoonful”, though they did not contain teaspoon or cups graduated in “teaspoonful” format. Volume calibration of the teaspoons (n=12, Mean±SD; 5.389±1.219 ml) showed statistically significant difference (P<0.05), while the cups volume capacities at 5.0 ml was found to be 5.200±0.326 ml. The cups with volume capacities of 10.0 ml (64.89%) or above 10.0 ml (35.11%) were found to be susceptible to error as only 25.5% of the mothers were able to accurately measure out 5.0 ml in the cups and also showed significant difference (P<0.05) in the group.

Wiesław Sawicki completed his PhD and DSc from Faculty of Pharmacy, Medical University of Gdańsk (Poland). He is the Head of the Department of Physical Chemistry, Dean (2008-2016) of the Faculty of Pharmacy, Medical University of Gdańsk and Member of several scientific and professional bodies. He is the Reviewer of ca. 200 manuscripts of publications and research projects- pharmaceutical technology - tablets, pellets, therapetic systems and physical pharmacy.

Pharmacokinetics of verapamil (V) and its metabolite norverapamil (NV), from buccal drug formulation (BDF) administered in a dose 20 mg in relation to conventional tablets of V 40 mg, used in medical practice, was determined. The employed BDF have a form of a thin elastic disc made of two layers. Composition of the dosing layer is: V 0.02 g; Povidone K-30 0.076 g; glycerol 0.0173 g; polyoxyethylene alkyl ethers (Brij 96) 0.0199. Diameter of the form is 10 mm; thickness is 0.38 mm. Composition of the protective layer is: Povidone K-30 0.152 g; glycerol 0.035 g. Diameter is 12.5 mm, thickness 0.5 mm. Conventional tablets Staveran 40 mg (Polpharma S.A., Starogard Gdański, Poland) were used as the reference drug. BDF has previously been designed as an alternative form of dosing V. Bioavailability was determined by a crossover method in 12 healthy volunteers. Drug concentration in plasma was determined by means of HPLC with a fluorescence detector. For BDF the average values of Cmax and AUC0-24h for V were much higher than for the reference Staveran 40 mg tablets and amounted to 51.28 and 320.23 ng/ml h, respectively. However, for NV the corresponding values for BDF were much lower than for a conventional tablet. It has been demonstrated that the proposed buccal V dosing ensures different metabolism of the drug as compared to tablets. Better parameters of bioavailability of V from BDF of twice a smaller dose than that in the tablet, prove that this new drug might be form more effective clinically than the conventional one. The above data indicate that V released from a BDF to buccal mucosa is quickly absorbed into the blood stream and undergoes metabolism in the liver to only a small extent. More favourable bioavailability parameters of V from a BDF compared to standard Staveran tablets containing twice the dose of drug is clear evidence that the buccal delivery from the system designed in our laboratory is promising.

Mariela Diaz Cinza is a senior student from Havana University. She is pursuing her practicum at the Center of Genetic Engineering and Biotechnology in Havana Cuba, a premier Biotechnological organization. She has participated in several scientific forums. She has participated in joint publications and researches. She has obtained many awards.

This poster presentation aims at sharing the experiences of a study carried out by a group of researchers who audited the quality at the Center of Genetic Engineering and Biotechnology in Havana Cuba, by means of its correct planning and control. For this purpose, bibliographical review was necessary as well as methods such as interviews, brainstorming, group decision-making and causes-effect diagrams. The application of the methods made it possible to carry out the diagnosis and analysis of the situation and to give a solution to the problem. The diagnosis showed that the activity does not guarantee a continuous improvement of the processes and quality system. Some actions were implemented, such as: Upgrading the procedures and forms of the activity, creating an organizational structure, and making audit programs to accomplish different activities and processes. These actions rendered remarkable results for audits, since they included the evaluation by suppliers, the internal audits and the protocols, final reports and critical phases of the preclinical and clinical tests.