bulk drug
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2022 ◽  
Vol 56 (1) ◽  
pp. 32-42
Yik-Ling Chew ◽  
Hon-Kent Lee ◽  
Mei-Ann Khor ◽  
Kai-Bin Liew ◽  
Bontha Venkata Subrahmanya Lokesh ◽  


Objective: This study aims to Formulate Mouth Dissolving Tablets (MDTs) of Tofacitinib Citrate with the increase in bioavailability and patient compliance. Methods: Mouth Dissolving Tablets (MDTs) of Tofacitinib Citrate were developed by full factorial design at 32levelsand prepared by direct compression method using super integrants like sodium starch glycolate, Ludiflash. The tablets were compressed into compacts on a 10 station tablet machine. The bulk drug was characterised by determining, MP, Solubility, pH and FTIR spectra. Results: The weight variation, hardness and diameter, thickness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies, and stability study, tablet thickness, weight variation and drug content post compression parameters remained consistent and reproducible. All the formulations showed, almost 100 percent of drug release within 75 min. Formulations F1, F2 and F3 were prepared with 5 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F1<F2<F3. Formulations F4, F5 and F6 were prepared with 10 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F4<F5<F6. Formulations F7, F8 and F9 were prepared with 15 mg of SSG and 20 mg, 30 mg, and 40 mg Ludiflash which shows % release of drug in the order of F7<F8<F9. Conclusion: It is concluded that the amount of superdisintegrants decreases disintegration time of tablets, decreases wetting time, increases the cumulative % drug release causes better absorption.

V. N. V. KISHORE ◽  

Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms. Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10 mmol Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column. Results: At 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 2 and) were estimated with ranging from 75–450 µg/ml for Tigecycline and 1–6 µg/ml for both impurity 1 and 2. The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 0.126 µg/ml). Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.

2021 ◽  
Carina CD Joe ◽  
Rameswara R Segireddy ◽  
Cathy Oliveira ◽  
Adam Berg ◽  
Yuanyuan Li ◽  

The Coalition for Epidemic Preparedness Innovations &rsquo &lsquo 100-day moonshot &rsquo aspires to launch a new vaccine within 100 days of pathogen identification. Here, we describe work to optimize adenovirus vector manufacturing for rapid response, by minimizing time to clinical trial and first large-scale supply, and maximizing the output from the available manufacturing footprint. We describe a rapid viral seed expansion workflow that allows vaccine release to clinical trials within 60 days of antigen sequence identification, followed by vaccine release from globally distributed sites within a further 40 days. We also describe a new perfusion-based upstream production process, designed to maximize output while retaining simplicity and suitability for existing manufacturing facilities. This improves upstream volumetric productivity of ChAdOx1 nCoV-19 by around four-fold and remains compatible with the existing downstream process, yielding drug substance sufficient for 10000 doses from each liter of bioreactor capacity. Transition to a new production process across a large manufacturing network is a major task. In the short term, the rapid seed generation workflow could be used with the existing production process. We also use techno-economic modelling to show that, if linear scale-up were achieved, a single cleanroom containing two 2000 L bioreactors running our new perfusion-based process could supply bulk drug substance for around 120 million doses each month, costing <0.20 EUR/dose. We estimate that a manufacturing network with 32000 L of bioreactor capacity could release around 1 billion doses of a new vaccine within 130 days of genomic sequencing of a new pathogen, in a hypothetical surge campaign with suitable prior preparation and resources, including adequate fill-and-finish capacity. This accelerated manufacturing process, along with other advantages such as thermal stability, supports the ongoing value of adenovirus-vectored vaccines as a rapidly adaptable and deployable platform for emergency response.

Satyabrata Sahu ◽  
U. Sunila Kumar Patra ◽  
Pratap Kumar Patra

Aim: In this present study an accurate reverse phase ultra-performance liquid chromatography (RP-UPLC) method has been developed, validated and applied to stability indicating studies to determine Lercanidipine HCL in bulk and marketed dosage form. Methods: Optimized chromatographic conditions were achieved by using Waters Acquity BEH C18 (2.1 x 50mm, 1.7m) UPLC column. Empower 2 is a software, dihydrogen Orthophosphate Buffer : Methanol (40 : 60)  as eluent at flow rate 0.3 ml/min. PDA detection was performed at 254nm. Results: The developed method was validated and stability study was conducted as per ICH guidelines. The retention time was found at 0.503 min. The method shows linearity over a range of 1 μg/ml to 60 μg /ml with the obtained correlation coefficient is 0.999. The LOD and LOQ values were found 0.025 and 0.05 μg /ml. The acidic and peroxide stressed study shows more degradation of 6.23% and 3.03%. Conclusion: The present developed method was found stability indicating, reliable, validated method was applied for the routine analysis of lercanidipine in bulk drug and the pharmaceutical formulations.

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