scholarly journals Systemic analysis about residual chloroform in PLLA films

2016 ◽  
Vol 2 (1) ◽  
pp. 49-52 ◽  
Author(s):  
Michael Teske ◽  
Daniela Arbeiter ◽  
Konstanze Schober ◽  
Thomas Eickner ◽  
Niels Grabow
Keyword(s):  
Thermal Characteristics ◽  
Drug Carriers ◽  
International Council ◽  
Systemic Analysis ◽  
Technical Requirements ◽  
Volatile Organic ◽  
Volatile Organic Chemicals ◽  
Polymeric Drug ◽  
The Common ◽  
Human Use

AbstractToxic volatile organic chemicals (VOCs), such as chloroform, are widely used in polymer manufacture in the field of implants and polymeric drug carriers. Several processes have to be carried out in order to remove toxic VOCs for patient safety without changing the thermal characteristics of the polymers. Therefore, we analyze the common commercial implant polymer poly(L-lactide) (PLLA) and screen different annealing- and rinsing processes considering influence on their morphology and thermal properties. For PLLA a rinsing step followed by annealing results in acceptable chloroform contents according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recommendations. Annealing processes reveal the lowest chloroform content after one day, which did not further decrease significantly with extended annealing time.

scholarly journals Systematic analysis about residual chloroform removal from PCL films

2018 ◽  
Vol 4 (1) ◽  
pp. 567-569 ◽  
Author(s):  
Michael Teske ◽  
Daniela Arbeiter ◽  
Konstanze Schober ◽  
Thomas Eickner ◽  
Niels Grabow
Keyword(s):  
Thermal Characteristics ◽  
Drug Carriers ◽  
Annealing Process ◽  
Drug Release Profile ◽  
Systematic Analysis ◽  
Treatment Processes ◽  
Technical Requirements ◽  
Volatile Organic ◽  
Polymeric Implants ◽  
Human Use

AbstractFor fabrication of polymeric implants and drug carriers volatile organic solvents, such as chloroform, are widely used. In order to remove solvents for patient safety several processes have to be carried out to avoid changes in the thermal characteristics of the polymers, as well as in the drug release profile and mechanical properties. We analyzed films of the polymer poly(ε−caprolactone) (PCL), a common commercial medical grade polymer which is widely used in implants and drug carriers. Considering the influence on the morphology and thermal properties we screened different post treatment processes. Acceptable chloroform contents according to recommendations of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) without changes in morphology and crystallinity were achieved via a simple annealing process for 24 h at 40°C and 40 mbar.

scholarly journals The importance of expert review to clarify ambiguous situations for (Q)SAR predictions under ICH M7

2020 ◽  
Vol 42 (1) ◽  
Author(s):  
Robert S. Foster ◽  
Adrian Fowkes ◽  
Alex Cayley ◽  
Andrew Thresher ◽  
Anne-Laure D. Werner ◽  
...  
Keyword(s):  
Quantitative Structure Activity Relationship ◽  
Quantitative Structure ◽  
Environmental Mutagen ◽  
International Council ◽  
Expert Review ◽  
Technical Requirements ◽  
Structure Activity ◽  
In Silico Predictions ◽  
Human Use ◽  
Selection Of

Abstract The use of in silico predictions for the assessment of bacterial mutagenicity under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M7 guideline is recommended when two complementary (quantitative) structure-activity relationship (Q)SAR models are used. Using two systems may increase the sensitivity and accuracy of predictions but also increases the need to review predictions, particularly in situations where results disagree. During the 4th ICH M7/QSAR Workshop held during the Joint Meeting of the 6th Asian Congress on Environmental Mutagens (ACEM) and the 48th Annual Meeting of the Japanese Environmental Mutagen Society (JEMS) 2019, speakers demonstrated their approaches to expert review using 20 compounds provided ahead of the workshop that were expected to yield ambiguous (Q)SAR results. Dr. Chris Barber presented a selection of the reviews carried out using Derek Nexus and Sarah Nexus provided by Lhasa Limited. On review of these compounds, common situations were recognised and are discussed in this paper along with standardised arguments that may be used for such scenarios in future.

scholarly journals Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada

2019 ◽  
Vol 9 (4-s) ◽  
pp. 673-679
Author(s):  
Nisar Ahammad ◽  
Nagarjuna Reddy ◽  
M.V. Nagabhushanam ◽  
Brahmaiah Ramakrishna
Keyword(s):  
Technical Information ◽  
Technical Document ◽  
Medical Products ◽  
International Conference ◽  
Registration Process ◽  
Regulatory Affairs ◽  
Technical Requirements ◽  
Drug Registration ◽  
The Common ◽  
Human Use

Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical Industry as it become compulsory for filing procedures.  The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Electronic common technical documentis an interface used by applicants of marketing authorisation for medical products to submit regulatory affairs document to the agency concerned. The purpose of this article is to present a concise overview of challenges faced during eCTD & CTD submissions in United States and Canada. A regulatory process, by which a person/organization/ sponsor/innovator gets authorization to launch a drug in the market, is known as registration process. The registration process will be done by submitting technical information to the authority Keywords: electronic common technical document (ECTD)/ (CTD), International conference on hormonisation (ICH), Drug registration process.

scholarly journals INDICADORES DE QUALIDADE EM INDÚSTRIA FARMACÊUTICA

2017 ◽  
Vol 29 (4) ◽  
pp. 364-370
Author(s):  
Ana Débora Nunes Pinheiro
Keyword(s):  
Drug Administration ◽  
Lean Manufacturing ◽  
Quality By Design ◽  
Food And Drug Administration ◽  
International Council ◽  
Technical Requirements ◽  
Human Use

A qualidade de processos industriais farmacêuticos e como obtê-la é um tema de grande interesse na indústria farmacêutica, principalmente no que diz respeito a sua padronização. Com a normatização dos guias de boas práticas farmacêuticas e a padronização das práticas, passou a ocorrer uma maior preocupação, inclusive governamental, com o que seria qualidade e como alcançá-la. O objetivo deste trabalho foi reunir os principais guias de referência e as práticas utilizadas como indicadores de qualidade na indústria farmacêutica. Para tanto, foram selecionados 21 trabalhos obtidos por meio de pesquisa em bancos de dados disponíveis online, além de guias de referência de organizações internacionais, como Organização Mundial da Saúde (OMS), Food and Drug Administration (FDA) e International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Após a organização e a leitura do material selecionado, foram descritas algumas práticas de qualidade atualmente utilizadas na indústria farmacêutica: gestão de risco, quality by design, ações corretivas e preventivas, lean manufacturing, sistema de qualidade total e séries ISO. Apesar de existir uma regulamentação bastante completa e atual acerca de indicadorese práticas de qualidade em indústria farmacêutica, as publicações não relatam informações específicas e experiências práticas da implementação desses sistemas de qualidade, dificultando assim, exemplificar melhor como essas estratégias influenciam positivamente no gerenciamento das indústrias farmacêuticas.

scholarly journals DEVELOPMENT OF ANALYTICAL METHOD FOR IMATINIB MESYLATE BY ULTRAVIOLET SPECTROSCOPY

2019 ◽  
pp. 180-183
Author(s):  
AJITHKUMAR P ◽  
ANTON SMITH A
Keyword(s):  
Imatinib Mesylate ◽  
Spectrophotometric Method ◽  
Analytical Method ◽  
Limit Of Detection ◽  
Pharmaceutical Preparation ◽  
Ultraviolet Spectroscopy ◽  
Limit Of Quantification ◽  
International Council ◽  
Technical Requirements ◽  
Human Use

Objective: A simple, selective, sensitive, specific, and spectrophotometric method has been developed for the detection of imatinib mesylate in pure form and formulations. Methods: The analytical condition was optimized for the drug, carried out as per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. Results: The drug shows absorption at 232.0 nm and obeyed beers law in the wide concentration range from 0.5 to 4.0 μg/ml. The lower limit of detection was found to be 0.331 μg/ml and the limit of quantification to be 1.004 μg/ml. The regression equation was found to be y = 0.08x. The precision of the method was found to be 99.04%±0.527% and the percentage of drug recovered by this method is 100.13%±1.375%. Conclusion: The method is simple and suitable for determination for imatinib mesylate in pure and pharmaceutical preparation.

A constructive critique of thedraftICH E9 Addendum

2019 ◽  
Vol 16 (4) ◽  
pp. 375-380 ◽  
Author(s):  
Daniel O Scharfstein
Keyword(s):  
Chronic Pain ◽  
Pain Medication ◽  
International Council ◽  
Technical Requirements ◽  
Human Use ◽  
Confirmatory Trial

In this article, I review the key elements of the proposed International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E9 Addendum, present a constructive critique, and provide recommendations of how it can be improved. To highlight ideas, I present a case study involving a confirmatory trial for a chronic pain medication.

scholarly journals VALIDATION STUDY OF STEROIDAL DRUGS (DEXAMETHASONE AND BETAMETHASONE) BY U.V. SPECTROPHOTOMETRIC METHOD

2018 ◽  
Vol 11 (7) ◽  
pp. 501 ◽  
Author(s):  
Khilav Anand ◽  
Astha Pandey
Keyword(s):  
Pharmaceutical Analysis ◽  
Linear Response ◽  
Spectroscopic Method ◽  
Distilled Water ◽  
International Council ◽  
Technical Requirements ◽  
Science Laboratories ◽  
Human Use ◽  
Development And Validation ◽  
Betamethasone And Dexamethasone

Objective: The present investigation involves development and validation of ultraviolet (UV) spectroscopic method for estimation of dexamethasone and betamethasone in a pharmaceutical dosage as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.Method: Betamethasone and dexamethasone were dissolved in 50 mL Methanol: water (1:2) and 50 mL distilled water, respectively. The method was validated for accuracy, precision, linearity, ruggedness, and robustness to check its consistency.Result: The λmax or the absorption maxima of both the drugs was found to be 241 nm. A linear response was observed in the range of 10–20 μg/mL.Conclusion: The method could be applied for the analysis of marketed tablets and also can be used for the routine analysis of dexamethasone and betamethasone in bulk formulations using UV method. It is suitable for the intended purpose especially in forensic science laboratories and other laboratories involved in the pharmaceutical analysis.

scholarly journals PIPERACILLIN ESTIMATION BY ION-ASSOCIATIVE COMPLEX FORMATION

2019 ◽  
pp. 159-163 ◽  
Author(s):  
GIRI PRASAD GORUMUTCHU ◽  
VENKATA NADH RATNAKARAM ◽  
KIRAN KUMAR KATARI
Keyword(s):  
Present Method ◽  
Absorption Maximum ◽  
Ion Pair ◽  
International Council ◽  
Technical Requirements ◽  
Bluish Green ◽  
Relative Standard ◽  
Amine Groups ◽  
Human Use

Objective: The objective of the study was to develop a simple, validated, and affordable visible spectrophotometric method for determination of piperacillin (PIP) present in bulk and powder for injection formulation. Methods: In the present method, cobalt thiocyanate (CTC) was used as a chromogenic reagent where it forms 2:1 ion pair complex at pH 2 with PIP which is having secondary and tertiary amine groups. Results: The formed bluish-green colored ion pair between PIP and CTC is quantitatively extractable into nitrobenzene with an absorption maximum of 665 nm. Regression analysis (r=0.9996) shows that the plotted calibration curve exhibits good linearity in the studied range of concentration (3–18 μg/mL). Low values of relative standard deviation (<2%) were observed indicating that the proposed method is reproducible, accurate, and precise. Conclusions: As per the existing guidelines of ICH (international council for harmonization of technical requirements for pharmaceuticals for human use), various parameters of the proposed method were tested for validation and can be used method of choice for routine analysis in industrial quality control laboratories, especially in developing countries.

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