Section 3: Production and Compounding最新文献

{"title":"3PC-036 Case study: development of an ointment according to the Pharmaceutical Inspection Convention guideline","authors":"L. P. Masiá, E. Rizkallal, M. Machetti, C. Lacasa, Mi Calvo, F. Martínez-Galán","doi":"10.1136/ejhpharm-2020-eahpconf.83","DOIUrl":"https://doi.org/10.1136/ejhpharm-2020-eahpconf.83","url":null,"abstract":"Background and importance Haemorrhoid treatment has a significant community and hospital pharmacy burden. Treatment options are varied but in non-severe cases, topical is usually the form of administration selected. In this ointment, three pharmacological effects are combined, mainly found in commercial forms through a simple manufacturing procedure, accessible to the facilities of a hospital pharmacy laboratory.1 The Pharmaceutical Inspection Convention, published in March 2014, is a guideline for healthcare establishments to ensure the quality of medicines manufactured in pharmaceutical services. Aim and objectives To develop a semisolid pharmaceutical form for haemorrhoid treatment. This form contained a vasoconstrictor, local anaesthetic and glucocorticoid. Application of the current guidelines to the elaboration of medicines in the hospital pharmacy was applied.2 Material and methods Material: ointment base—vaseline, paraffin and levomenthol; APIs—phenylephrine hydrochloride, lidocaine hydrochloride and hydrocortisone. Equipment: electronic analytical scale pinacle; Agilent Series 1100 with quaternary pump and diode array detector; and ThermoScientific Haake Viscotester 550. The organoleptic characteristics and rheologic properties were assessed. Content homogeneity of the three APIs was proved through a high performance liquid chromatography (HPLC) validated method.3 Results A manufacturing system in the hospital pharmacy was developed following the concept of quality by design.4 A quality assurance system was established to supervise the whole manufacturing process and documentation. Full pharmaceutical characterisation was developed, including the development and validation of a HPLC method to quantify the three APIs in the ointment. Conclusion and relevance This work corroborates the fact that application of these guidelines in combination with the International Conference of Harmonisation instructions is both feasible and convenient in terms of manufacturing medicinal products in healthcare establishments. This methodology will be implemented in the manufacture of more complex medicinal products in subsequent work. References and/or acknowledgements 1. Brown SR. Haemorrhoids: an update on management. Ther Adv Chronic Dis 2017;8:141–147. 2. Pharmaceutical Inspection Convention. Guide to good practices for the preparation of medical products in healthcare establishments, 2014. 3. International Conference on Harmonisation of technical requirements for the registration of pharmaceuticals for human use. Validation of analytical procedures: Text and Methodology Q2 (R1). Geneva, 2005. 4. International Conference on Harmonisation of technical requirements for the registration of pharmaceuticals for human use. Endorsed guide for ICH Q8/Q9/Q10 Implementation. Geneva, 2011. No conflict of interest.","PeriodicalId":335223,"journal":{"name":"Section 3: Production and Compounding","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133804696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"3PC-067 Abstract withdrawn","authors":"","doi":"10.1136/ejhpharm-2019-eahpconf.148","DOIUrl":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.148","url":null,"abstract":"Background Management of the anticancer treatments remainders is improved thanks to the centralisation of preparations. In our unit, remainders stored at 4°C are placed in transfer containers kept in a refridgerator. Remainders are regularly exposed to ambient temperatures. Today, no transfer system can respect the cold chain of remainders. Purpose Improvement in practices and respect of the anticancer product’s cold chain. Material and methods A follow-up of container’s temperature evolution was carried out over a period of 3 hours, simulating the routine activity: three successive exposures of the container 20 min at ambient temperature followed by 40 min in a refridgerator. These measurements were repeated three times with and without refrigerated eutectic plates for a total of 1080 measurement points. A comparison of temperature’s evolution was made with and without eutectic plates. The average of each measurement point, the SD as well as the median and average over the study period, were calculated. Results The maximum temperatures in the containers were 12.1°C without eutectic plates and 11.1°C with eutectic plates. The remainders from the refridgerator are better preserved thanks to the eutectic plates. In addition, eutectic plates decrease temperature variations in the container with a SD of 2.4°C without ice bread and 1.4°C with eutectic plates. However, the average temperatures in the container were 8.6°C with eutectic plates versus 7.8°C without eutectic plates, and the median was 8.7°C with eutectic plates and 7.5°C without eutectic plates. The temperature of the container with eutectic plates is higher than that without eutectic plates, which is explained by the fact that the container cools less quickly with an eutectic plate. Conclusion Eutectic plates reduce temperature variations of containers for a half-day of activity but do not offer a satisfactory solution for controlling the cold chain. In the future, industries should provide a solution to this problem to improve the quality of cyotoxic preparations. References and/or acknowledgements BPP, AFSSAPS 2007. No conflict of interest.","PeriodicalId":335223,"journal":{"name":"Section 3: Production and Compounding","volume":"40 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128557281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"3PC-062 Abstract withdrawn","authors":"","doi":"10.1136/ejhpharm-2019-eahpconf.143","DOIUrl":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.143","url":null,"abstract":"Background Initial and continuous team’s training of centralised chemotherapy preparation units (CCPU) is a key point in the control of this risky production process. In our unit, initial training was realized in another hospital. We decided to develop an internal initial training programme, in order to better meet the needs of the centre: flexibility and adaptation to the activity. Purpose The objective was to set up a training programme concerning manipulation under a laminar flow in a CCPU, and educating pharmaceutical assistants and interns to carry it out. Material and methods Theoretical and practical content of the training have been determined using good handling practices, approved by the whole team (pharmacists and pharmaceutical assistants) and prepared. After validation at the establishment level, the training was then implemented by an intern and a pharmaceutical assistant. Results The training consists of three parts: To learn theoretical knowledge of chemotherapies, legislation and good handling practices by way of written material and two interviews (30 min and 2 hours) with a pharmacist. To adopt practical skills, via 2 hour training sessions by pharmaceutical assistants sensitised to good practices, who have an updated continuing training. It was evaluated with the carrying out of a fluorescein test. To gain knowledge of the functioning of the unit, current procedures and behaviour expected, under the supervision of a referent pharmaceutical assistant. It was validated by a competency grid. The final assessment was realised by the referent pharmacist with a practical evaluation of the respect for safety rules during a real preparation under a laminar flow. A licence for preparation of cytotoxic drugs within the CCPU summarising these three points is prepared by the pharmacist and maintained as evidence of training. Conclusion Two team members were trained with the programme. Its evaluation through a satisfaction questionnaire showed positive results. After this successful completion, the programme will be pursued to train the next team members. A cost analysis is ongoing, but it already has allowed a reduction in the formation time and the mobilisation of the entire staff concerning the issue of initial formation of new members. References and/or acknowledgements Introduction and validation of an initial training in a centralised chemotherapy preparation unit. No conflict of interest.","PeriodicalId":335223,"journal":{"name":"Section 3: Production and Compounding","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126375815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"3PC-068 Abstract withdrawn","authors":"","doi":"10.1136/ejhpharm-2019-eahpconf.149","DOIUrl":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.149","url":null,"abstract":"Background The emergence of novel potent active pharmaceutical ingredients (APIs) and genetic tests highlight the necessity of creating personalised medicinal formulations, containing amounts of APIs tailored to suit each patient’s individual needs. Also, polypharmacy and lack of adherence to pharmacotherapy indicates the need for manufacturing formulations that can incorporate more than one APIs to facilitate patient compliance. Purpose 3D printing of pharmaceutical formulations can provide a solution to the aforementioned issues. Moreover, the ability of 3D printing to create elaborate dosage forms paves the way for the introduction of complex formulations into clinical practice. With that perspective, we created three different pharmaceutical dosage forms via 3D printing. Material and methods For the creation of the 3D printed formulations a fused deposition modelling (FDM) 3D printer was used. The first formulation, a three-layered, ring-shaped formulation containing hydrochlorothiazide (HCTZ) aimed at inducing zero-order release kinetics of the API.1 The second one comprised an insoluble matrix with its bottom consisting of a polymer with pH-dependent solubility and loaded with beads containing the chemotherapeutic agent 5-Fluorouracil (5-FU). This formulation was designed to release the API at high pH values in order to select the site of release in the gastrointestinal tract.2 The third one incorporated two APIs with different dosage regimens (metformin and glimepiride) into matrices with distinct release properties for combined pharmacotherapy using a single dosage form (poly-pills).3 Dissolution tests were conducted in order to assess in vitro performance of the formulations, performed at conditions simulating different segments of human gastrointestinal tract according to USP specifications. Results All formulations were functional, as the first presented the desired zero-order release of HCTZ (R2=0.990), the second released 5-FU at pH values>7.2, indicating its capability for targeted colonic delivery, and the third one released both APIs within acceptable time margins (achieving immediate release of glimepiride and sustained release of metformin, in 2 and 8 hours respectively), indicating the potential for co-administration of APIs with different dosage regimens in the same personalised dosage form. Conclusion 3D printing can revolutionise pharmacotherapy in numerous ways. In this work we presented three of them: personalisation, API combination and release modulation by shape modifications. References and/or acknowledgements 1. https://www.sciencedirect.com/science/article/pii/S1773224717302721 2. https://link.springer.com/article/10.1208%2Fs12249-018-1084-2 3. https://www.sciencedirect.com/science/article/pii/S0928098718301799?via%3Dihub No conflict of interest.","PeriodicalId":335223,"journal":{"name":"Section 3: Production and Compounding","volume":"162 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134070603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"3PC-038 Abstract withdrawn","authors":"","doi":"10.1136/ejhpharm-2019-eahpconf.119","DOIUrl":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.119","url":null,"abstract":"Background In many hospital preparations in the form of syrups, dilution is often necessary, such as chloral syrup and chloral-containing bromide syrup diluted to 4.5% and 37%, respectively. But what is the degree of dilution that preserves the microbiological stability of the syrup? Purpose The aim of this work is to evaluate the anti-bacterial strength of various simple syrup forms after gradual dilutions with distilled water and artificial contamination of dilutions with a reference bacterium. Material and methods We prepared hot and cold sucrose syrup, fructose syrup and glucose syrup. The four syrups were then diluted at levels between 5% and 50% with distilled water artificially contaminated with Escherichia coli ATCC 25922 and then incubated at 37°C for 24 hours. The incubated dilutions were then seeded on CLED AGAR under sterile conditions. The inoculated boxes were also incubated at 37°C for 24 hours to 48 hours. A glucose assay by Architect c16000* in hot and cold sucrose solutions was conducted in the search for probable decomposition of sucrose into glucose and fructose. Results The appearance of the bacterial growth for the dilutions of the four solutions of glucose, cold sucrose, hot sucrose and fructose was respectively 9%, 15%, 35% and 45%. The glucose assay in the cold and hot sucrose solutions was 0.0 g/L and 0.11 g/L, respectively. Conclusion This simple study makes it possible to say that we can dilute a hospital preparation in the form of syrup for preparation needs at levels ranging from 9% to 45%, depending on the sugar and the method of preparation used. The fructose syrup is at the top for its antibacterial capacity followed by hot sucrose syrup and the cold one, leaving the glucose syrup last. Therefore, hospital preparations based on simple syrup of hot sucrose have more microbiological stability than those based on cold sucrose syrup. The appearance of fructose in hot sucrose syrup seems to be at the origin of its better microbiological stability. References and/or acknowledgements No conflict of interest.","PeriodicalId":335223,"journal":{"name":"Section 3: Production and Compounding","volume":"53 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121113781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}