Observing the today hospital practice in many countries and the international literature involved it is clear How clinical pharmacy is linked to the galenic laboratory practice. Today more then recent past due to the various kind of magistral formula request by the clinicians It is necessary that the clinical pharmacist perpesctive must to be added to the classic GALENIC laboratory competencies: this make possible to complete the profile of efficacy and safety of this fundamental  Drugs. The clinical galenic activity is divided in sterile and Non sterile. (Total parenteral nutrition bags, Pain therapy, oncological parenteral drugs laboratory, radio drugs and diagnostics, non sterile galenics). Aim of this work is to deeply investigate this crucial link (CLINICAL PHARMACY with LABORATORY PRACTICE) in order to get the really best clinical results for the patients. Clinical pharmacy principle, PHARMACEUTICAL care, managerial competencies and personalized pharmacy added to the best knowledge and competencies in galenic laboratory make the difference in order to obtain the right final clinical results. The same in this work are submitted to international pharmacy practioner, directors and researcher the  Normatives rules operating in an advanced country: the semplified italian NBP, example that can be applied also in non advanced nations. In italy pharmacist can follow or the full NBP of the official pharmacopeia or the semplified according  DM Salute 18.11.2003. ( related the kind of galenic formula  if sterile or not)

The NBP (good manifacturing rules) introduce an QUALITY SYSTEM MANAGEMENT.

The full NBP are more used in more complex laboratory in example involved in specialistic products  Like oncologic or radiopharmaceutical and other. Aim of this rules is to guarantee quality, security and efficacy of a drug prepared in galenic lab. This are based on resonsability principles, plan, documentation of all activity. (QUALITY SYSTEM OF ASSURANCE) All phases of the preparation are under the responsability of the pharmacist. The final quality depends on the correct use of API (ACTIVE PRINCIPLE) and eccipients, the right calculations operation, right volume or weight operation, and following the right procedure. Check on the final products:  folowing of the procedure, aspetcs, pakaging and its closure. According NBP the laboratory must to be separated (or it must to be separable) form the 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 striclty enviromental condition to make possible to prepare in safety way the drugs. And it is mandatory must to be followed written procedure. (the instrument verify, training of the pharmacist)Cleaning procedure, sanifications. Raw material certifications, technical sheet, safety sheet. Working sheet is mandatory. The pharmacist can follow this two option related the kind of drugs produced and the characteristic of the laboratory. It is not the main focus of this work to produce a literal translation of DM 18/11/03 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 non advanced countries.                                                                                                                        

Starting from the consideration that in history of the remedy fot the pathology of humans great contribute was obtained with the introduction of GALENIC principle and methods. From GALENUS form Pergamon (Greek) 129 dc – 201 comes the term GALENIC art of the pharmacist to produce drugs inside in the pharmacy.He codified the preparation of drugs using multiple kinds of ingredients. (active principle added with excipients). For many centuries this methods was used in the laboratory to produce remedy to treat many human pathology. Federico II Svevia 1194 – 1250 knowed as “ STUPOR MUNDI “ related his open mind  concepts introduced In europe and in italy the need to have specific rules  for regulation the activity of drugs production in the pharmacy laboratory from the prescription activity of the physicians.

This in order to avoid conflic of interest between this prescrictive funtion form the pharmacy practice:

this produced the mandatory separation between medicine and pharmacy.: to the phisicians the role in therapy and responsible for prescriptions of durgs  and the pharmacyst responsible for production and sell of the drugs . But during the illuministic  period , the industrial revolution , the succes of medicinal chemistry since 1800 and 1900 many forces make possible to shift the drugs production form the pharmacty to the  more complex industry . During all this periods many FORMULARY and then PHARMACOPOEIA in various countries was introduced and adopted To make possible to get adeguate quality of the drugs produced, safety and reproducibility  of the procedure. (monography, methods of analisys ,table et other )This texts becomes mandatory by  healthcare law in the various  contests ( FU italian, FU european,  US pharmacopeia and many other examples).

Also the competencies of who was involved in remedy preparation increased during centuries :

from botanic experties (SCUOLA SALERNITANA VII e VIII century ) to the IATROCHEMISTRY principle   PARACELSUS from  XVI century ) . Before the pharmacists, apothecaries that worked alongside priests and physicians in regard to the  patient care. The history of pharmaceutical history is well knowed form introduction of the first SULFAMIDICS since the  Actual last antivirals (for covid-19 treatement). But, related the last industrial pharmaceutical revolution ,some problem arosed :  not all prarmaceuticals industries produce drgus for all subpopulation (pediatric patients, swallowing problems in geriatrics). There is the needs of personalizaed dosages or personalized pharmaceutical form (for pediatric or geriatric patients) needs to introduce drugs in enteral nutrition drugs not available form national or foreign producers (national or international shortcomings)

orphan drugs for some rare disease 

dermatologic products 

cannabis preparates 

some disifectants band antiseptics formula 

some antidothes (galenics)

some laboratory reagents and solutions 

some contrast agents 

odontoiatric galenics

and many other  So due to this failure of industry to cover all this situation the galenic laboratory is a real opportunity.Today also many pharmaceutical industry not like more to produce classic drugs as many cardioactive products and other and the magistral product make possible to overcome this problem. ( expcially today whit actual economic crisis) . Also a great number of  galenic formula are in use commonly in the hospital : corrosive products for dermatologist, alcool solution for laboratory,  various reactives , phitotherapic derivates and so on . Galenic Pharmacy  also provides educational, scientific and research activities in the profile discipline – pharmaceutical technology to the pharmacy  student or under specilization programs. But observing international literature it is possible to see that the best clinical resulats are obtained when the laboratory activity in production magistral formula by the phyicians is completed when available  the clinical pharmacist and managerial competecies in the same team. Galenics is the  laboratory process that turns an active ingredient  (API) into a ready-to-use medicine that can be dosed as required for the various patients .  This to optimise their absorption. It the discipline (or science) of dosage form design. According Review  Braz. J. Pharm. Sci. 56  2020 https://doi.org/10.1590/s2175-97902019000418358    Preparation of extemporaneous oral liquid in the hospital pharmacy Márcio Robert Mattos da Silva Letícia Pereira Dysars Elisabete Pereira dos Santos E. Ricci Júnior “At the hospital, the pharmacist is constantly challenged to prepare extemporaneous solutions ES from tablets, capsules or drug powder for patients unable to swallow, Like  as pediatric, elderly and patients that use nasoenteric and nasogastric tubes. The preparation of extemporaneous solutions  ES from capsules, tablets and drug powder requires stability studies analysis”

Figure 1: manual encapsulator, an expample of instrument used in galenic laboratory

Figure n 2: galenic laboratory, an example of  solution preparation by the pharmacist

With and observational point of view an review of relevant article ( references form 1-16 ) related the topics of this work is performed .

It is produced the meaning translation of an Italian normative rule DM 18 NOV 2003

An practical experimental study is reported with results from 2008 to 2023 .

Finally a global conclusioni is submitted to the researcher related also innovations in fields of Galenic laboratory.

Review RESULTS

FROM LITERATURE 

J Pharm Pract. 2021 Jun 15;8971900211023643. doi: 10.1177/08971900211023643. 

Hospital Pharmacy Response to Covid-19 Pandemic in Italy: What We Learned From the First Outbreak Wave

Vera Damuzzo , Riccardo Bertin , D. Mengato , M. Chiumente , Melania Rivano , Angelo Claudio Palozzo 

DOI: 10.1177/08971900211023643

“ When COVID-19 pandemic started, the Italian hospital pharmacists faced multiple challenges and change their work practices.

The aim of this study  work was to describe the impact of  the C-19 emergency on pharmaceutical care  (PC) provided by pharmacists during the first wave of the pandemic. Issues related to pharmacist's involvement in the pandemic management PM  were: changes in activities, support received by authorities and pharmacists' own perceived role in the Health System HS .

A cross-sectional study worl based on a web survey was conducted between May and June 2020 collecting information from pharmacists, members of Italian Society of Clinical Pharmacy and Therapeutics SCPT. 113 (11.4%) completed the questionnaire. The cohort was divided in two arms: pharmacists who worked in severely C-19 affected areas (High Spread Regions) and those employed in the less affected areas (Low Spread Regions).

The changes in the pharmacy work settings PWS reflected the increase of logistics area and non-sterile clinical galenic, and reduction of clinical tasks. 

The most demanding challenge was referred to shortages of medical devices MD and drugs, 61/113 pharmacists reported difficulty in obtaining products compliant to quality standards. National Institutions and the Regional Governments provided a greater perceived support. More than about 50% of participants felt that their role did not change if compared to other healthcare professionals.

Despite some limitations related to their clinical activity, pharmacists played a relevant l role in supplying personal protective equipment, medical devices MD and medications to improve health outcomes during this emergency. The results may guide pharmacists in future actions to improve the management of the pandemic. “(6)

Croat Med J. 2014 Dec;  doi: 10.3325/cmj.2014.55.662

Establishment of galenic laboratories in developing countries to produce high quality medicines: results of Aid Progress Pharmacist Agreement (A.P.P.A.®) Project

Francesca Baratta, A. Germano, Gaetano Di Lascio, Richard Petieau,and Paola Brusa

“Aid Progress Pharmacist Agreement Project: aims in developing countries

Aid Progress Pharmacist Agreement (A.P.P.A.®) is a non-profit NP association based on a voluntary work and its main activity is the A.P.P.A.® Project. The Project started in  the 2005 as a result of the cooperation between the Pharmacy Faculty of Turin (TO) and Italian community pharmacists. Its main task is the establishment of galenic laboratories (GLs) in hospitals of developing countries (DCs) according to the principles of international health cooperation.

- establishing GLs in DCs with the aim of preparing medicinal products MP that comply with quality requirements, first of all to fight the widespread counterfeiting of medicines in DCs;A

-tailoring the dosages and pharmaceutical forms PF according to the actual patient needs;

-employing the  local staff, teaching them a “new job,” and opening a suitable school;

-minimizing the   costs necessary to prepare these medicines.

There are  relevant and important reasons why galenics should be used:

i) a low cost of the production system and simple operative procedures;

ii) the possibility to adapt  the dosages and pharmaceutical forms PF to the patients’ needs and medical prescriptions;

iii) reduction in the use of counterfeit medicines CM  in the settings where the GL is located. “(7)

Study protocol  08 January 2018

Impact of collaborative pharmaceutical care on in-patients’ medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study)

Géraldine Leguelinel-Blache, Christel Castelli, C.Roux-Marson, Sophie Bouvet, Sandrine Andrieu, Philippe Cestac, Rémy Collomp, Paul Landais, B. Loulière, Christelle Mouchoux, Rémi Varin, Benoit Allenet, MEDREV Working Group, Pierrick Bedouch & Jean-Marie Kinowski 

“The clinical pharmacist CP will have a collaborative meeting with both the prescriber and the nurse in order to notify any possible medication errors  ME and suggest any proposals to optimize the AMO according to the medical history, the clinical status CS , and the therapeutic adherence . ( change of galenic form due to swallowing problem, dose adjustment to renal function RF ). After the collaborative meeting, the clinical pharmacist will check whether the prescriber has accepted his/her suggestion(s) and modified the AMO. All the pharmaceutical interventions,  the medication errors  ME detected and the pharmaceutical suggestions of order modification, will be collected and characterized in a standardized form according to the French Society of Clinical Pharmacy FSCP “ (8) JDDG: Journal der Deutschen Dermatologischen Gesellschaft Topical preparations and their use in dermatology J. Wohlrab  23 November 2016 https://doi.org/10.1111/ddg.13151 “The choice of a pharmaceutical (galenic) concept is primarily based on the requirements of the physico-chemical properties  PCP of the active ingredient to be applied. The fixed combination of active pharmaceutical ingredients  API in topical preparations is suitable for only a limited number of clinical treatment scenarios.” (9) Hospital Pharmacology. 2015; Information on the Quality of Substance for the Preparation of  Pharmaceutical Drugs in Terms of  Hospital Pharmacy   M. Dj. Jovović , Maja M. Ribar “Compliance with national legislation,  like as establishing compliance prescribed by the  European legislation EL  in the field of drug development is binding. All manufacturers of drugs and/or active pharmaceutical ingredients  PI  must apply quality standards prescribed by the European Pharmacopoeia EP  in order to develop, manufacture and sales of  medicines. When it comes to the quality of  pharmaceutical ingredients PI for the production  of drugs in the pharmacy, pharmacies especially in residential institutions in our country  is permanently done by harmonizing national  legislation NL in order to improve conditions for  the preparation and production of galenic  drugs  GD in terms of inpatient health institutions  performed in a manner that is prescribed by  international regulations. Th is requires the adaptation of institutions, including the  fundamental changes in competence as national professional and administrative and regulatory rules  that apply to state- and private sectors “(10)

ORIGINAL ARTICLE

DOI: 10.1016/j.rppede.2016.02.012 Magistral drugs in hospitalized newborns and childrenMedicamentos magistrais em recém-nascidos e crianças hospitalizados Agueda Cabral de Souza Pereira, Elaine Silva Miranda, S. Rodrigues de Castilho, Débora Omena Futuro, Lenise Arneiro Teixeira, Geraldo Renato de Paula Universidade Federal Fluminense (UFF), Niterói, RJ, Brazil “The constant consumption of magistral oral solutions MOS and suspensions by newborns and children of the assessed hospital indicates the need for such preparations as a pediatric therapeutic alternative in this hospital.”(11)

Luisetto, M et al (2017). Editorial The Clinical Pharmacists Main Focus Journal of Applied Pharmacy, 2017, Vol.09(04)

Mauro LUISETTO et al (2015). UK Journal of Pharmaceutical and Biosciences Vol. 3(6), 67-72, 2015 RESEARCH ARTICLE Pharmacist Cognitive Service and Pharmaceutical Care: Today and Tomorrow Outlook 

Fiazza C, Ferraiuolo A,Luisetto M, Sahu R. (2020).Galenic hospital laboratory during COVID-19 emergency: A practical experience in an advanced country. Int J Clin Virol.; 4: 118-125.

Mauro Luisetto,(2017).Attitudes and Skills in Business Working Settings: A HR Management Tool Business and Economics Journal Mauro, Bus Eco J 2017, 8:1 

m.luisetto et al (2016).management instrument in pharmaceutical care and clinical pharmacy Intern. journal of economics and management sciences Luisetto et al., Int J Econ Manag Sci 2016, 5:5

Vera Damuzzo , Riccardo Bertin , Daniele Mengato , Marco Chiumente , Melania Rivano , Angelo Claudio Palozzo (2021).J Pharm Pract. 2021 Jun 15;8971900211023643. Online ahead of print. Hospital Pharmacy Response to Covid-19 Pandemic in Italy: What We Learned From the First Outbreak Wave PMID: 34126804 

Francesca Baratta, Antonio Germano, Gaetano Di Lascio, Richard Petieau, and Paola Brusa(2014) .Establishment of galenic laboratories in developing countries to produce high quality medicines: results of Aid Progress Pharmacist Agreement  Journal List Croat Med J  v.55(6); 2014 Dec  PMC4295074 Croat Med J. 2014 Dec; 55(6): 662–668. (A.P.P.A.®) Project 

Géraldine Leguelinel-Blache, Christel Castelli, Clarisse Roux-Marson, Sophie Bouvet, et.al (2018).Study protocol Open Access Published: 08 January 2018  Impact of collaborative pharmaceutical care on in-patients’ medication safety: study protocol for a   stepped wedge cluster randomized trial (MEDREV study) Trials volume 19, Article number: 19 (2018) 

Johannes Wohlrab (2015), Topical preparations and their use in dermatology  JDDG: Journal der Deutschen Dermatologischen Gesellschaft First published: 23 November 2016 

Marija Dj. Jovović , Maja M. Ribar (2015).Hospital Pharmacology. 2015; 2(1):220-224 UDC: 615.014.2 Information on the Quality of  Substance for the Preparation of Pharmaceutical Drugs in Terms of  Hospital Pharmacy 

Débora Omena Futuro, Lenise Arneiro Teixeira, et.al (2015).Magistral drugs in hospitalized newborns and children Medicamentos magistrais em recém-nascidos e crianças hospitalizados   Agueda Cabral de Souza Pereira, Elaine Silva Miranda, Selma Rodrigues de Castilho, Brazil

Dooms, M., Carvalho, M. (2018). Compounded medication for patients with rare diseases. Orphanet J Rare Dis 13, 1 

Jovanović Lješković,Aleksandra Jovanović Galović,Svetlana Stojkov, Nikola Jojić,   Slobodan Gigov Umberto Musazzi (2021). Medicine Shortages in Serbia: Pharmacists’ Standpoint and Potential Solutions for a Non-EU Country Nataš, Pharmaceutics. 2021 Apr; 13(4): 448. 2021pharmaceutics13040448

Guendalina Zuccari , Silvana Alfei , Danilo Marimpietri , Valentina Iurilli , Paola Barabino  Leonardo    Marchitto (2022). Valid Strategy to Combine Efficacy and Safety in Pediatrics Pharmaceuticals (Basel). 17;15(1):108.

Seoane-Viaño , Sarah J. Trenfield , Abdul W. Basit , (2021). Drug Delivery Reviews Translating 3D printed pharmaceuticals: From hype to real-world clinical applications  Alvaro Goyanes Advanced Drug Delivery Reviews Volume 174, July 2021, Pages 553-575 Advanced 

Giuseppe Manini , Emeric Carlier, JeaDooms, M., Carvalho, M. Compounded medication for patients with rare diseases. Orphanet J Rare Dis 13, 1 (2018). https://doi.org/10.1186/s13023-017-0741-y 04 January 2018 “When there is no on-label or even no off-label treatment for the patients with rare diseases  RD pharmacists have to compound the medication.”(12) Pharmaceutics. 2021 Apr;  2021 Mar 26. doi: 10.3390/pharmaceutics13040448 Medicine Shortages in Serbia: Pharmacists’ Standpoint and Potential Solutions for a Non-EU Country Nataša Jovanović Lješković, A. Jovanović Galović, Svetlana Stojkov,Nikola Jojić, and Slobodan Gigov Umberto Musazzi “Backup manufacturing on a small scale (magistral and galenical) could be a good way to overcome some kind of shortages.”(13) Pharmaceuticals (Basel). 2022 Jan , Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics Guendalina Zuccari , Silvana Alfei , D. Marimpietri , V. Iurilli , Paola Barabino , Leonardo Marchitto  DOI: 10.3390/ph15010108 “In the treatment of pediatric diseases PD , mass-produced dosage forms are often not suitable for children. Commercially available medicines CAM are commonly manipulated and mixed with food by caregivers at home, or extemporaneous  kinds of medications are routinely compounded in the hospital pharmacies HP to treat the hospitalized children. Despite considerable efforts by regulatory agencies RA, the pediatric population is still exposed to questionable and potentially harmful practices. When designing medicines for children, the ability to fine-tune the dosage while ensuring safety of the ingredients is of paramount  and crucial importance. For these  kind of scope solid formulations may represent a valid alternative to liquid formulations for their simpler formula and more stability, and, to overcome the problem of swelling ability, mini-tablets could be a practicable option. This review work deals with the different approaches that may be applied to develop mini-tablets intended for pediatrics with a focus on  safety of the excipients. Alongside the various conventional method of compression, 3D printing appeared particularly appealing, as it allows to reduce the number of ingredients and to avoid both the mixing of powders and intermediate steps like as granulation. this technique could be well adaptable to the daily galenic preparations of a hospital pharmacy HP, thus leading to a reduction of the common practice of off-label preparations. “(14) Volume 174, July 2021 Advanced Drug Delivery Reviews Translating 3D printed pharmaceuticals: From hype to real-world clinical application Viaño , Sarah J. Trenfield , A. W. Basit , Alvaro Goyanes https://doi.org/10.1016/j.addr.2021.05.003 “Three-dimensional (3D) printing offers the potential to revolutionise the production of pharmaceuticals targeted to the gastrointestinal GI tract by offering a flexible drug product manufacturing platform that can adapt readily to changing market and patient needs . By using digital computer-aided design software to produce medicines in a layer-by-layer manner, 3D printing enables the on-demand production of drug products DP with personalised dosages PD , drug combinations , geometries  and release characteristics ; a concept which is currently unattainable and cost inefficient with conventional manufacturing technologies ( tabletting and encapsulation). This technology has been forecast to disrupt a wide range of pharmaceutical applications, ranging from expediting the drug development process DDP and providing benefits for pharmaceutical manufacture, to on demand printing of personalised medicines PM  on the front-line and in hard-to-reach areas . “(15) International Journal of Pharmaceutics Volume 569, 5 October 2019 Feasibility study into the potential use of fused-deposition modeling to manufacture 3D-printed enteric capsules in compounding pharmacies Christoph Nober , Giuseppe Manini , Emeric Carlier , Jean-Marie Raquez , S. Benali , Philippe Dubois , Karim Amighi , Jonathan Goole  https://doi.org/10.1016/j.ijpharm.2019.118581 “The purpose of this  research work was to investigate the feasibility to manufacture enteric capsules, which could be used in compounding pharmacies , by fused-deposition modeling. It is well-known that conventional enteric dip coating of capsules CPS  in community pharmacies  CP or hospitals is a time-consuming process which is characterized by an erratic efficacy. Fused-deposition FD  modeling was selected as a potential 3D printing method due its ease and low-cost implementation LCI . Before starting to print the capsules CPS , an effective sealing system was designed via a computer-aided design program. Hot melt extrusion was used to make printable enteric filaments. They were made of the enteric polymer, a plasticizer and a thermoplastic polymer, namely Eudragit® L100-55, polyethylene glycol 400 and polylactic acid, respectively. Riboflavine-5′-phosphate was selected as a coloured drug model to compare the efficacy of the 3D printed capsules to that of enteric dip coated capsules as they are currently produced in community pharmacies and hospitals HP . Different parameters of fabrication which could influence the dissolution profile of the model drug, such as the layer thickness or post-processing step, were studied. It was demonstrated that our 3D printed enteric capsules did not release the drug for 2 h in acid medium (pH 1.2). They completely dissolved within 45 min at pH 6.8 which allowed the release of a minimal amount of 85% w/w of drug as it was recommended by the European Pharmacopoeia EP 9th Edition for enteric products.”(16an-Marie Raquez , Samira Benali  Philippe Dubois , Karim Amighi , Jonathan Goole (2019).International Journal of Pharmaceutics Feasibility study into the potential use of fused-deposition modeling to manufacture 3D-printed  enteric capsules in compounding pharmacies Volume 569, International Journal of Pharmaceutics 

Figure 3: from https://doi.org/10.1016/j.ijpharm.2019.118581

Practical project 

In this part are analyzed the italian normative rules named NBP and semplified as  DM Salute 18.11.2003 norme di buona preparazione” applied by law as mandatory in the galenic laboratory setting inside the pharmacy ( public or private – hospital and comunity ).

NBP or GMP good manifacturing practice 

The GMP philosophy are based on :

documentation of the process , registrations,  every phases of the process, activity and single operations.

- team must receive  adeguate training 

-responsability clearly identified

-Quality of API and eccipients 

- cleaning and sanitization procedure 

-Regular check of the instruments

- process validation

- NC non conformity management

So In italy by law the pharmacist that  work in a  galenic laboratory  according DM 22/06/05  must to follow or  the FULL NBP of ITALIAN FU  ( more complex) or  DM Salute 18.11.2003 ( if not sterile magistral  preparations or officinal reduced scale  ) The pharmacy that prepare non sterile magistral formula or officinal reduced scale can follow or full NBP or semplified NBP. Instead if prepared sterile products , or toxic preparates ,  anticancer drugs and radiodrugs, it must to be used biological hood : it is mandatory to follow full NBP. For non sterile products it is possible in italy to deviate from  full NBP and to follow the semplified rules if it is possible to keep under control all the process , prooving it. (quality efficacy, safety depends on organization and consistent control) .First NBP was introduced in (FU IX ed.) in 1989.In the chapter 795 USP, pharmaceutical compounding of non sterile products,  related the difficulty of the preparations, its stability , storage conditions, dosage form , complexity in calculations,sistemic, topic use, risk level for pharmacist, damage risk for patients are classified 3   situations :simple compounding , moderate and complex compounding . It is request to produce the master formulation records and the compounding record. Like NBP the USP rules are based on the quality of final products and on the documentation of all process. Some preparations  at high microbiological  quality  need to be prepared in zone with HEPA FILTER . A translation of  the  meaning of the Semplified NBP  an its phylosophy  (DM Salute 18.11.2003 ) and  their meaning are reported : Application field  :( non sterile magistral and officinal forms reduced lots) for hospital and comunity pharmacy medical prescription for magistral formula and Pharmacopeia for Officinal reduced scale production)  Preliminar evaluation about opportunity -possibility to prepare the galenic requested or needed

definitions: magistral formula, officinal, reduced batch

laboratory hygienic  written procedure, frequency  ( provided by director of the pharmacy or lab. Responsible). lab area: it must to be adequate to the kind of galenic products produced, ceiling and walls wahable it can be in a separate room separate or not separate  inside the pharmacy.

instruments: mandatory according PHARMACOPEA uff. ITALIAN table n. 6, the measure insntrument must to be verified in regular way. The refrigerattor must to be cleaned. Containers (and related certificate of conformity to pharmacopeia requirement of the primary contaniners). 

Raw material : chemical denomination, date of arrive in pharmacy , batch number , expiration date or date of retitulation, certificate of analisys signed by producer ( according pharmacopeia quality  requirement), conservation condition or use, date of first use . ( necessary a register of raw materials , eccipients and API, with a progressive  numeration). The empty container of raw material must to be keeped for 6 month after final use. Fulfillments   ( preventive and after setup  )  to the preparations . Prescription verify, normative requirement ,  sign of the phisician, iperdosages verify  ( according table n. 8 pharmacopeia italy), Incompatibility verify , the possibility to prepare in lab. After setup: to be writed on the prescription the progressive number of the preparartion, date of the praparation, expiration date, eccipients used, precautions and cautions, label must to be attached. Sign of the pharmacist  in the label , on the prescription or on the working sheet Labeling etichettatura – batch number and expiration date, composition qualitaticve quantitative , API Eccipients , date limits for use, precautions,  Price ( comunity pharmacy) Douments storage -conservazione documentazione ( time )  , emplty  bottle . The written prescritption must to be kepped in pharmacy for 6 month and the same working sheet. (working sheet). The prescription of narcotics must to be keeped in pharmacy for the time required by normative rules. Quality control: right following of the procedure, organolectic characteristics, control  of the pakaging, sealing of the container , righ label compilation, mass uniformity ,acceptation limits A copy of the label must to be attached to the working sheet Documentation : of the working space, instruments, raw materials

xpiration time of the drugs prepared : accordin FU requirement : 30 days that can be prolonged to 6 month  acording chemico -phisical microbiological stability documentated by official informations.

Mandatory equipment and  tools utensili in pharmacy a  ( TABLE N 6 pharmacopea italian  in force)

1. balance sensitivity to the  mg , scale = 0,001 g, loading capacity  at least 500 g or  in alternative way two different balances , one  with sensitivity at the  mg (d=0,001g) with loading capacity at least  50 g and the other with sensitivity at  0,50 g (d=0,50 g) with  carry load at least of  2 kg.

2. Bain marie  or other equipement that can assure ,in heating , temperature since to  100 °C. 

3. Fridge able to  assure the right  storage conditions  according pharmacopeia requirement

4. Point of fusion  equipement . ( to test the raw material)

5. chemical glassware, also graduated  sufficient for the  execution of the preparation. 

6. percolator – at empty Concentrator   (1). 

7. encapsulator  (2) 

8. Tablet press (3). 

9. powder Aspiration system  (4). 

10. moulds or plastic valve for ovules and suppositories (5). 

11.tools and devices necessary to guaranteee sterility of the preparation (6)

Beyond the reported instruments, the pharmacy must have all other instruments,equipements ,tools , materials,  products and reactive  adequate to the  number end to the  nature of the preparations usually  performed and of suitable tools for their check to be done according the  the Pharmacopeia indications.

Pharmacy that execute injectable preparations must have also materials, equipements, and tools   essential to this preparations an for all the control expected by pharmacopeia for this specific kind of preparation.

Note:

1)– mandatory for pharmacy that prepare extracts. they must to be of marterials and adequate dimension to the volume and related the preparation to be executed.

(2) - mandatory for the pharmacy that prepare capsules. 

(3) – mandatory for the pharmacy that prepare tablets . 

(4) – mandatory for pharmacy that prepare tablets, capsules, capsule, teas  or sachets . 

(5) – mandatory for pharmacy that prepare suppositories and ova .

(6) -  for pharmacy that prepare sterile products.

In order to evaluate the application of REDUCED NBP in an hosp.  galenic lab PC AREA are reported 

The all official non conformity registered from 2008 to 2023. (the internal production) 

Results: no major non conformity registered related the preparation activity . (for the non serile galenic activity), only 2 secondary- minor NC  due by an excipient to be modified to increase solubility of an API  and related  a closing system for  an oral power .

As reported in this work are clear the advantages to produce some kinds of drugs in a galenic laboratory.

Even the industrial epoca , with the  pharmaceutical industry increase , the industrial production of drugs 

Was rapidly developed and so reduced or  stopped  the production in the galenic laboratory : 

this process was due to The complexity process to produce with high quality the finished drugs in the amonut requested by the hospital and the patient.

But the same some condition needed to manteign this procedure : for magistral prescription  single patient based and for the production of disinfectants, reagents or other product.

It must also to be remembered that during LAST COVID-19 PANDEMIA one of the main producers of antispetic gel hands and alcoolic solution was the hospital pharmacy in their lab as well as in the private pharmacy.

The industry in this situation was not   able to provide ready to use great amount of this product in few time as needed for the public safety. (3)

The galenic hospital laboratory in the public hospital was able to guarantee this production and the safety of the patient and healthcare professional.

The results of a practical experience  reported  show also in a specific settings the goodness of this rules NBP  even if semlified .

The technological innovation make possible to better cover the need for drugs shortcomings.

Comparing full NBP to the reduced DM 10nov 2003 it is possible to verify that NBP require separate or separable locals , chek by other pharmacist   vs the one that prapare the drug in lab., and required as mandatory written procedures accreditated .

For DM it is not mandatory complex quality check on the final products, no mandatory written procedure are needed  (even if suggested).

In this work it is also submitted a new technology useefull in galenica laboratory : the 3D PRINTING SYSTEM 

As an innovation for quality and efficiency of the process.

Limitations of the work: the practical experience submiteed is related only to on local centre even if a great hospital that cover the need of  about 200.000 citizens ( populations) .

As conclusion it is possible to say that observing the Italian Reduced NBP rules in an advanced countries 

can be applied also in non advanced countries with great benefit for healthcare of the patients.

Related the specific preparation requested by the clinicians.

This rules report general behavior and procedure to be followed to be sure that the durgs produced are safe and useful for the patiens.

Not all laboratory in the world have the same intruments or complex laboratory, but in every laboratory 

It is crucial to know the responsability as well as procedure adopeted (quality control of raw material,

active substantie, qualification of the pharmacist, traceability of the lots and other.)

For this reason it is opinion of the author that this rules must to be translated in their general meaning from italian to english languages as  reported in this work.

 The authors submit to the reseachers and pharmacists a new innovative tool: the 3D PRINTING systems for galenic laboratory use : a system to increase global efficiency of the preparation of capsules or other pharmaceutical form during a period of drug shortages.

 no

 considered all rules