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Recent Advancements of Additive Manufacturing for Patient-Specific Drug Delivery
Published in Atul Babbar, Ankit Sharma, Vivek Jain, Dheeraj Gupta, Additive Manufacturing Processes in Biomedical Engineering, 2023
Prakash Katakam, Shanta Kumari Adiki, Soumya Ranjan Satapathy
Oral solid dosage forms are considered the oldest and the most renowned drug formulations and are cheap, noninvasive, and easy to use by patients. Several dosage forms exist such as pills, tablets, capsules, lozenges, pellets, and films. However, the fixed-dose combination therapy (FDCT) in which two drugs are placed in a single tablet. This may not offer patient-specific dosage flexibility. Moreover, poly-therapy might worsen medication adherence, which may cause further deterioration of the health of patients. A single patient-specific formulation that combines all the drugs needed for patients with chronic diseases can considerably improve adherence to treatment and patient compliance. By using AM technologies, multiple drugs can be administered in a formulation of tailor-made shape, size, and desired drug release profiles by avoiding traditional methods [51–52].
The Role of Polymers in Solid Oral Dosage Forms
Published in Ijeoma F. Uchegbu, Andreas G. Schätzlein, Polymers in Drug Delivery, 2006
Richard A. Kendall, Abdul W. Basit
The therapeutic effect of drugs that have a short biological half-life may be enhanced by formulating them as extended- or sustained-release dosage forms. Extended- and sustained-release dosage forms prolong the time that systemic drug levels are within the therapeutic range and, thus, reduce the number of doses the patient must take to maintain a therapeutic effect, thereby increasing compliance. Drugs with a narrow therapeutic index are also suitable for incorporation into an extended-release dosage form, where the peaks associated with Cmax can often be dampened, reducing the possibility of systemic side effects occurring when drug levels in blood exceed the minimum toxic concentration. Unlike an immediate-release dosage form, where disintegration and drug release occurs rapidly in the stomach, extended-release formulations release the drug gradually as the dosage moves along the gastrointestinal tract. Extended-release dosage forms are commonly proposed as a formulation tool for achieving zero-order drug release; however, zero-order release in vitro rarely translates to constant drug absorbance and drug blood levels in vivo because of the heterogeneous composition of, and transit rate through, the gastrointestinal tract (see Table 4.1).
Manufacturing and Process Control Issues
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
Alan Fauconnier, Lyudmil Antonov
The concept of biosimilarity emerged in the early 2000s, when the patents of innovative biotechnological medicinal products expired and/or when they started losing data protection, opening the door to the application for the marketing authorization of putative biological generics. Regulators promptly realized that the abbreviated procedures at that time might not be appropriate for licensing biological medicinal products, or “biologics.” Indeed, these procedures, namely the abbreviated new drug application (ANDA) in the United States and the derogation granted by the European Union (EU) to essentially similar medicinal products, usually referred to as generics, are intended for the marketing authorization application (MAA) of products that are “essentially comparable” to a reference, originator, or innovator medicinal product. The generic and its reference must have the same qualitative and quantitative composition in active substance and the same dosage form and route of administration. On this basis, full nonclinical and clinical development is not required, and clinical studies are usually reduced to bioavailability studies aimed at demonstrating bioequivalence. In essence, the generics approach relies on the availability of chemical pharmaceutical and biological documentation compiled and presented in the Quality/CMC part of the application. The quality development is expected to bring the information needed for establishing the comparison between the generic and its reference. Since chemical entities can be subjected to in-depth and precise characterization, this allows drawing a reliable picture of the drug and determining its quality, facilitating the comparability exercise between the generics and its reference.
Designing and evaluation of dermal targeted combinatorial nanostructured lipid carrier gel loaded with curcumin and resveratrol for accelerating cutaneous wound healing
Published in Particulate Science and Technology, 2023
Ajay Singh, Mohammad Kashif Iqubal, Saurabh Mittal, Farheen Fatima Qizilbash, Ali Sartaz, Shobhit Kumar, Javed Ali, Sanjula Baboota
Various product attributes are analyzed and monitored for their effect on product quality and all these attributes serves as a tool to quality by design (QbD) (Yu et al. 2014). Objective of QbD is to find out the effects of various critical quality attributes (CQAs) up on product quality. Quality target product profile (QTPP) is initial stage in developing formulation and it summarizes the quality attributes i.e., physical and chemical attributes of the target product. QTPP principally consists of crucial product characteristics, which must be closely monitored during the product development process. These characteristics include dosage form type, dose, mode of administration, pharmacokinetics, and stability.
Improved skin-permeated diclofenac-loaded lyotropic liquid crystal nanoparticles: QbD-driven industrial feasible process and assessment of skin deposition
Published in Liquid Crystals, 2021
Tejashree Waghule, Shalini Patil, Vamshi Krishna Rapalli, Vishal Girdhar, Srividya Gorantla, Sunil Kumar Dubey, Ranendra Narayan Saha, Gautam Singhvi
While developing a product using a QbD-oriented approach, the first step is to define the quality target product profile (QTPP). It majorly includes the dosage form, dosage strength, and route of administration of the formulation taking into account its safety, efficacy, and quality. Critical quality attributes (CQAs) are those properties of the formulation that might have an impact on the physicochemical, biological, and microbiological activity [22,23].