Pharmaceutical Drug Product Development and Process Optimization

2020 ◽  
Keyword(s):  
Product Development ◽  
Process Optimization ◽  
Drug Product ◽  
Pharmaceutical Drug

Flexibility in Drug Product Development: A Perspective

2021 ◽  
Author(s):  
Yash Kapoor ◽  
Robert F. Meyer ◽  
Heidi M. Ferguson ◽  
Daniel Skomski ◽  
Pierre Daublain ◽  
...  
Keyword(s):  
Product Development ◽  
Drug Product

scholarly journals Container Closure and Delivery Considerations for Intravitreal Drug Administration

2021 ◽  
Vol 22 (3) ◽  
Author(s):  
Ashwin C. Parenky ◽  
Saurabh Wadhwa ◽  
Hunter H. Chen ◽  
Amardeep S. Bhalla ◽  
Kenneth S. Graham ◽  
...  
Keyword(s):  
Adverse Events ◽  
Product Development ◽  
Drug Product ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Volume Determination ◽  
Common Procedure ◽  
Drug Products ◽  
Fill Volume ◽  
Container Closure

AbstractIntravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.

Recent Advances in Liposomal Drug Product Development

Yakhak Hoeji ◽  
2021 ◽  
Vol 65 (4) ◽  
pp. 246-257
Author(s):  
Jae Cheon Kim ◽  
Dong Hee Na
Keyword(s):  
Product Development ◽  
Drug Product ◽  
Liposomal Drug ◽  
Recent Advances

Quantification and In Silico Toxicity Assessment of Tazarotene and its Impurities for a Quality and Safe Drug Product Development

2019 ◽  
Vol 57 (7) ◽  
pp. 625-635 ◽  
Author(s):  
NVVSS Narayana Murty Nagulakonda ◽  
Ravi Shekar Ananthula ◽  
T Krishnamurthy ◽  
Muguda Ravi Prasada Rao ◽  
Gollapalli Nageswara Rao
Keyword(s):  
Product Development ◽  
In Silico ◽  
Limit Of Detection ◽  
Drug Product ◽  
Acne Vulgaris ◽  
Toxicity Assessment ◽  
Limit Of Quantification ◽  
Related Substances ◽  
In Silico Toxicity

Abstract Tazarotene is internationally accepted common name for ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. It is a synthetic retinoid used for the topical treatment of mild to moderate plaque psoriasis, acne vulgaris and photo aging. To ensure the quality of drug product and drug substance, a LC–MS compatible UHPLC method was developed for quantification of drug and its related substances. Stationary phase with fused core particle technology is used for the separation of impurities. Limit of quantification and limit of detection of the method are 0.1 and 0.03%, respectively. Precision of the method for Tazarotene and all its related substances is less than 2.2% RSD. The correlation coefficient is >0.999. Accuracy of method is ranged from 95.3% to 107.0%. Application of this method in stability analysis has been demonstrated by analyzing stressed samples. Experimental design is used for the verification of robustness of the method. To ensure the safety, an in silico toxicity of the drug and its related substances were determined using TOPKAT and DEREK toxicity predictions Both UHPLC and in silico methods were validated as per the ICH Q2 and ICH M7 guidelines, which will enable a rapid product development of Tazarotene topical formulations while ensuring the safety and quality of product.

Sign in / Sign up

Export Citation Format

Share Document