Galenic Laboratory: State of the Art-A Scientific and Technological Discipline, Innovation and Management

Authors: Luisetto M*, Naserr A, Khaled E, Mashori GR, Benzi CR, Fiazza C, Cabianca L and Yurevich OL

DOI: 10.23880/oajpr-16000316

Volume 8, Issue 2

Abstract

The term galenic imply a scientific and technical matter but also an art. Related the hospital practice the future of pharmacy pass though the innovation of the galenic lab. Observing the today hospital practice HP in many countries and the international literature involved it is clear how clinical pharmacy is linked to the galenic lab practice LP. Today more than recent past due to the various kinds of magistral formula requested by the clinicians It is necessary that the clinical pharmacist CP perspective must to be added to the classic galenic lab competencies: this make possible to complete the profile of efficacy and safety of this fundamental and crucial Drugs like the magistral formula and officinal and their use. Aim of this ancient discipline and art is today to provide efficacy and safe drugs for the need of single patient when it is not possible to use the industrial product. The clinical galenic activity can be divided into sterile and non-sterile. (Total parenteral nutrition TPN bags, Pain therapy, oncological parenteral drugs lab UFA, radio drugs and diagnostics and non-sterile galenics).Aim of this work is to deeply investigate this relevant link (Clinical Pharmacy CP with Lab Practice LP) in order to get the really best clinical results for the patients and healthcare org need. Clinical pharmacy CP principle, Pharmaceutical care PC, the managerial competencies and personalized pharmacy added to the best knowledge and competencies in the galenic lab. Make the difference in order to obtain the right final clinical results. The same in this work are submitted to the international pharmacy practitioner, directors, researcher or students the Normative rules operating in an advanced country like Italy: the simplified NBP (NORME DI BUONA PREPARAZIONE), example that can be applied also in the non-advanced nations. In Italy pharmacist can follow or the full NBP (NORME DI BUONA PREPARAZIONE) rules of the official pharmacopeia or the simplified according DM Salute 18.nov.2003. (Related the kind of galenic formula prepared if sterile or not). The NBP (NORME DI BUONA PREPARAZIONE) (good manufacturing rules) introduce a QUALITY CQ SYSTEM MANAGEMENT. The full NBP (NORME DI BUONA PREPARAZIONE) are more used in more complex labs in ex. involved in specialist products (Like oncologic or radio drugs, sterile colliria and other). These rules guarantee the quality, security and the efficacy of a drug prepared in galenic lab. These are based on the responsibility principles, plan, and documentation of all activity. (QUALITY SYSTEM OF INSURANCE CQ). All the phases of the preparation are under the responsibility of the pharmacist. The final quality of the products depends on the correct use of API and excipients, on the right calculations operation, right volume measure or weight operation and the Check on the final products: -following of the procedure, aspects, pakaging and closing system and other request by ITALIAN FU related the specific pharmaceutical form. According NBP (NORME DI BUONA PREPARAZIONE) the lab. Must to be separated (or it must to be separable) form the rest of pharmacy and a second pharmacist (that is different form the pharmacist that prepare) must to check the final preparation. The locals must to be according strictly environmental condition required normative rules by to make possible to prepare in safety way drugs. And it is mandatory to follow the written procedure: instrument verify, training of the pharmacists Cleaning procedure, significations. For Raw materials: it is needed to have certifications, technical sheet, safety sheet, data of the first use, expiry data Working sheet is mandatory to testify the operations. The pharmacist can follow this 2 option related the kind of drugs produced and the characteristic of the lab. It is not the main focus of this work to produce a literal translation of the DM 18/nov /2003 only to submit its general meanings. This can be considered for the authors useful to be added also to the normative rules in force in other non-advanced countries. In order to make more interesting this book some useful concepts of physiology of the stomach and GI tract are reported. The same relevant pharmaceutical concepts and technique with a focus on the capsules CPS as pharmaceutical form (gastro resistance, delayed release), some oral suspension, gels and other few preparation. This work is produced whit a non-conventional approach: it is not a book of pharmaceutical technique. Innovation and management of the system make possible to increase the power of the galenic laboratories In the hospital or in private pharmacy. This work is produced only for international purpose.

Keywords: Physiology; Galenic Lab; Magistral Formula; Clinical Pharmacy; Pharmaceutical Care; Personalized Pharmacy; Drug Shortage; NBP; Simplified Rules; Official Pharmacopeia; Control Process; Quality Management System; Rare Disease; 3D Printing Systems; Management

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