International Journal of Drug Delivery 9 (2017) 101-106 http://www.arjournals.org/index.php/ijdd/index Original Research Article Quality control and standardization Of faca ® syrup Salfo Ouédraogo* 1 , Sidiki Traoré 1 , Jean Claude W. Ouédraogo 1 , Moumouni Koala 1 , Lazare Belemnaba 1 , Noufou Ouédraogo 1 , Felix Kini 1 , Sylvin Ouédraogo 1 , Innocent Pierre Guissou 1,2 *Corresponding author: Salfo Ouédraogo 1 Département Médecine Pharmacopée Traditionnelles et Pharmacie, Institut de Recherche en Sciences de la Santé (MEPHATRA-PH /IRSS), 03 BP 7192 Ouagadougou 03, Burkina Faso. 2 Laboratoire de Pharmacologie- Toxicologie/Unité de Formation et de Recherche en Sciences de la Santé (UFR/SDS), Université de Ouagadougou, 03 BP 7021 Ouagadougou 03, Burkina Faso. Received: 15 July 2017 Accepted: 25 October 2017 Published: 23 January 2018 Abstract Sickle cell disease is a major public health problem. It is the first genetic disease in the world. FACA syrup offers an alternative treatment. It is a dry powder preparation of two components, the roots barks of Zanthoxylum zanthoxyloides Lam. (Rutaceae) Zepernick, Timler and Calotropis procera. Ait. R.B.r. (Asclepiadaceae). The product was developed at Institute for Research in Health Sciences (IRSS) from a traditional recipe used in Burkina Faso for treatment of sickle cell crises. This study aimed to establish physical-chemical, pharmaco technical and microbiological control parameters essential for the standardization of the phytomedicine. This valuation concerned specifications of moisture content, pH, the fingerprint by thin layer chromatography, pesticide residues, heavy metal content, microbial quality, and total ash. These charcteristics were determined by the methods prescribed by the World Health Organization (1998) and the European Pharmacopoeia 6th edition. The results have shown that dry syrups and reconstituted syrups were sweet, slightly spicy with a bitter after taste, a white room color and a faint odor. The density at the preparation was 0.985 and the pH was 5.93. After 2 months of storage in the laboratory, the organoleptic parameters of the reconstituted syrups have not changed. They were mold free, the density remained around 1 and the pH between 5 and 4. These parameters have shown that the quality of plants powders and this medicine comply with the recommendations of the European pharmacopoeia. Faca syrup may contribute to the better management of sickle cell disease in children. Keywords: FACA syrup, sickle cell disease, plant powder, medicinal plant, quality control. Introduction Sickle cell disease is a major public health problem. It is the first genetic disease in the world [1] and affects about 4% of the world’s population. In Africa, prevalence is estimated between 5% and 7% with highest frequency in sub-Saharan [2]. In the United States, the disease affects more than 70,000 African Americans. In Central Africa and Madagascar, 20 to 30% of the populations are healthy carriers of the sickle cell disease gene [3]. Each year, nearly 2% of newborns are affected by the disease and 50-75% die before the age of 5 [4, 5]. Optimizing treatment is a major challenge for any health program [6,7]. Thus, using an approach based on ethnopharmacology, the Department of Traditional Medicine and Pharmacopoeia of the Institute of Research in Health Sciences has demonstrated the antifalcemic properties of the combination of two plants Zanthoxylum zanthoxyloides and Calotropis procera with clinical confirmation in humans [8, 9]. This phytomedicine in the form of capsules obtained its marketing authorization in 2010 and is listed in the list of essential drugs in 2011 in Burkina Faso [2, 10]. Through the Phytomedicine Production Unit (U-PHARMA) this pharmaceutical form is marketed in many countries around the world. It has earned several innovation awards including the first prize of the International Forum of Inventions and Technological Innovations in 2011 in Niger and the 10th National Forum for Research and Technological Innovation in 2012 in Burkina Faso Faso. However the administration of capsules by infants being difficult or impossible, a standardization study of the root bark powder of Zanthoxylum zanthoxyloides for the production of pediatric anti- sickle cell phytomedicine was carried out [11, 12]. To ensure uniformity of all batches of the drug in syrup form. It is necessary to establish an appropriate standard for identity, purity, content, behavior and other characteristics. It is the strict observance of these standards that makes it possible to obtain the desired quality. This study aimed at galenic formulation and quality control in view of the standardization of FACA syrup. Materials and Methods Raw materials and syrups Raw materials were root bark powders from Zanthoxylum zanthoxyloides (code: Ts) and Calotropis procera (code : Cp). Three (03) batch of dry syrup made from a mixture of the two powders were used for this study (code : Fs1; Fs2; Fs3). The powders were ISSN: 0975-0215 DOI:10.5138/09750215.2166 This article is distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use and redistribution provided that the original author and source are credited.