Preformulation in Drug Research and Pharmaceutical Product Development

Acharya, Pratap Chandra; Shetty, Saritha; Fernandes, Clara; Suares, Divya; Maheshwari, Rahul; Tekade, Rakesh K.

doi:10.1016/b978-0-12-814423-7.00001-0

Cited by 6 publications

(7 citation statements)

References 86 publications

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“…For pharmaceutical industry considerations, drug discovery and data mining tools have made the industrial process quick to reach. This is a kind of opportunity used by the scientists working in various research and development teams of the pharmaceutical industry are working at foremost for generating the new drug concept and brand development for the industry [18]. Using modernised data science tools, the entire product life cycle is being transformed by this technology like discovery biology and medicine research and development, production, and validation.…”

Section: Pharmaceutical Drug Product Life Cyclementioning

confidence: 99%

“…Deliquescent substance absorbs moisture to a greater extent and liquefies themselves hence, they dissolve solids and leave a thin water film on their surface. This process is linked with relative humidity conditions, this condition measured by vapour diffusion and heat transport rates [18].…”

Section: Observations Properties Referencementioning

confidence: 99%

“…Preformulation research is performed to generate data related to biopharmaceutical, physicochemical, and physic-mechanical properties of molecules, and adjuvants (Figure 2) [16,17]. These analytical investigations inspire formulation strategies and manufacturing methods for drug substances and drug products [18].…”

Section: Introductionmentioning

confidence: 99%

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Preformulation Studies: A Versatile Tool in Formulation Design

Ahirwar¹,

Shukla²

2023

Drug Formulation Design

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The physicochemical properties of pharmacological molecules have a tremendous effect on safety and efficacy. Poor physicochemical properties can often make it hard to set up a reliable structure-activity relationship (SAR) with no prominent efficacy in preclinical and clinical models. This can lead to more variability in capability and higher drug development costs in the entire development process, and in the worst case, even to stop the clinical trials in the later period. Understanding the basic physicochemical properties makes it possible to separate and untangle investigational observations hence poor molecular properties can be changed or fixed during the design phase. This makes it more likely that the molecule will make it through the long and difficult development process. The decline in innovator pharmacotherapeutics number registrations decline each year and the industry is under even more pressure than in the past to speed up the drug development process. This reduces the length of time required for development and introduces innovative pharmaceutical products. To do this, it is imperative to proceed with an organised approach and act appropriately the first time. The current chapter aims to focus on the important physicochemical properties of the selected molecule, along with how those properties are evaluated and implicated in both discovery enablement and final dosage form development.

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Section: Pharmaceutical Drug Product Life Cyclementioning

confidence: 99%

Section: Observations Properties Referencementioning

confidence: 99%

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Preformulation Studies: A Versatile Tool in Formulation Design

Ahirwar¹,

Shukla²

2023

Drug Formulation Design

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“… The process strategy will influence output overall Phase II vaccine trials Vaccine safety and effectiveness are the core of every development. Execution of the administrative processes is essential [ 34 ] It should be thoroughly investigated prior to the beginning of Phase II trials. The changes introduced at this point could be Phase I or Phase II R&D testing.…”

Section: Vaccination Processmentioning

confidence: 99%

COVID-19 pandemics Stage II – Energy and environmental impacts of vaccination

Klemeš

Jiang

Fan

et al. 2021

Renewable and Sustainable Energy Reviews

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The COVID-19 pandemic developed the severest public health event in recent history. The first stage for defence has already been documented. This paper moves forward to contribute to the second stage for offensive by assessing the energy and environmental impacts related to vaccination. The vaccination campaign is a multidisciplinary topic incorporating policies, population behaviour, planning, manufacturing, materials supporting, cold-chain logistics and waste treatment. The vaccination for pandemic control in the current phase is prioritised over other decisions, including energy and environmental issues. This study documents that vaccination should be implemented in maximum sustainable ways. The energy and related emissions of a single vaccination are not massive; however, the vast numbers related to the worldwide production, logistics, disinfection, implementation and waste treatment are reaching significant figures. The preliminary assessment indicates that the energy is at the scale of ~1.08 × 10 10 kWh and related emissions of ~5.13 × 10 12 gCO 2eq when embedding for the envisaged 1.56 × 10 10 vaccine doses. The cold supply chain is estimated to constitute 69.8% of energy consumption of the vaccination life cycle, with an interval of 26–99% depending on haul distance. A sustainable supply chain model that responds to an emergency arrangement, considering equality as well, should be emphasised to mitigate vaccination's environmental footprint. This effort plays a critical role in preparing for future pandemics, both environmentally and socially. Research in exploring sustainable single-use or reusable materials is also suggested to be a part of the plans. Diversified options could offer higher flexibility in mitigating environmental footprint even during the emergency and minimise the potential impact of material disruption or dependency.

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“…The general objective of combining one or more disintegrants in the formulation is to enhance the surface area of the dosage form and soften the binding substance and associate together the solid granules that make up the final product. The total effects is that a tablet when disclosed to aqueous media disintegrates first into granules, and then into fine particles 6,7 . The rate of dissolution increases as the particle size reduces and is greatest when the tablets or capsules reduced to fine colloidal particles.…”

Section: Introductionmentioning

confidence: 99%

Modification of natural hydrocolloid as disintegrant in aceclofenac tablet formulation

Gupta

Manigauha

2021

J. Drug Delivery Ther.

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The purpose of present exploration was to modify kappa (k)-Carrageenan, by crosslinking, and assessed it as a tablet disintegrant to strengthen the solubility of the drug (aceclofenac) in tablet formulation. Modified k-Carrageenan was synthesized by reacting it with epichlorhydrin at heterogenous conditions. The swelling action of the product was investigated in order to optimize reaction circumstances for chemical cross-linking. Best modified k-Carrageenan procured by optimizing the reaction conditions and it was characterized for swelling index, particle size distribution, solubility, viscosity, gel strength and Fourier transform infrared spectroscopy (FTIR). Influence of modified k-Carrageenan on dissolution profile of therapeutic was also investigated along with other evaluation parameters. Modified k-Carrageenan exhibiting significant swelling index which is comparable to that of superdisintegrants. On comparative investigation as a tablet disintegrant by preparing anhydrous dicalcium phosphate tablet, modified k-Carrageenan showed disintegration time less than 20 seconds. Dissolution of aceclofenac (Class II) tablet formulaion utilizing modified k-Carrageenan was comparable with commercially available superdisintegrants. Faster dissolution of the accommodated drug was achieved with modified k-Carrageenan which was comparable with dissolution of the tablet formulation containing other superdisintegrants. The competent concentration of k-Carrageenan was found to be 5-15% as tablet disintegrant. Modified k-Carrageenan might be encouraging tablet disintegrant in fast dissolving formulations and can be worn in direct compression method. Keywords: k-Carageenan. Epichlorhydrin. Aceclofenac. Crosslinking. Superdisintegrant

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Preformulation in Drug Research and Pharmaceutical Product Development

Cited by 6 publications

References 86 publications

Preformulation Studies: A Versatile Tool in Formulation Design

Preformulation Studies: A Versatile Tool in Formulation Design

COVID-19 pandemics Stage II – Energy and environmental impacts of vaccination

Modification of natural hydrocolloid as disintegrant in aceclofenac tablet formulation

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