The global cosmetic market prized $532.43 billion USD in 2017 is expected to reach $805.61 billion USD by 2023, with a 7.14% compound annual growth rate. These figures have appealed to the cosmeceutical players for developing new and effective products containing advanced materials. Cosmetics incorporated with pharmaceutical actives, termed as ‘cosmeceuticals,’ are receiving an overwhelming response from cosmetic industry. Nowadays, the implementation of nanotechnology for enhanced effectiveness of cosmeceuticals is witnessing a huge success. These applications include remedies for hair damage, wrinkles, aging and skin dryness. Currently, there is a need to establish regulations and harmonized guidelines for nanotechnology-based products to assess their efficacy, safety and toxicity profiles. This review summarizes current development, applications, safety and regulations of nanocosmeceuticals.
Background: Oseltamivir Phosphate (OP) is an ethyl ester prodrug prescribed for the treatment of influenza virus infection. Current marketed formulations of OP supplemented with an adverse effect observed during postmarketing surveillance. These prerequisites are sufficed by developing a sustained release Dry Powder for Inhalation (DPI). Objectives: Objective of the present study was to develop OP-DPI by an innovative formulation approach comprising of Immediate (IR) and Sustained (SR) Release portions. Methods: DPI formulation comprised of an IR and SR portions were prepared by spray drying technique using Hydroxy Propyl Methyl Cellulose (HPMC) as the rate-controlling polymer for SR portion. The spray-dried product further characterized for various pharmaco-technical, in-vitro and in-vivo parameters. Results: OP-DPI showed burst release of 49% within 15 min and further sustaining the drug release up to 9 hrs. The in-vitro aerodynamic performance of OP-DPI showed maximum deposition at stage 3 and Fine Particle Dose (FPD) of 1.08 mg indicating deposition in the upper respiratory tract. Solid state characterization by DSC and XRD indicated the partial amorphization OP due to spray drying. In-vivo toxicological examination revealed no sign of inflammation, indicating the safety of the developed formulation. Accelerated stability study as per ICH guidelines displayed no significant change in the solid-state characterization and drug related performance of OP-DPI. Conclusion: Prepared novel and scalable OP-DPI may have potential to overcome the problems associated with existing marketed dosage forms of OP. Further, localized drug delivery of the antiviral drug through pulmonary route might be clinically benefited in controlling the viral proliferation.
The purpose of the present review is to summarize the current pediatric regulatory requirements and also the regulatory efforts that need to be taken for the potential benefits of safety and efficacy to the pediatric patients. The importance of pediatric regulations came into existence as adult physiological conditions differ from that of children; therefore, the same dosage regimen cannot be recommended for both. Children deviate from adults with respect to pharmacokinetic and pharmacodynamic characteristics, and hence the effect of the drug has to be reconfirmed for pediatrics. Drugs used in pediatric clinics are often considered as “therapeutic orphans” throughout the world as they are difficult to develop and are not provided with sufficient information. The number of clinical trials performed in children is not sufficient. At present, laws and regulations aimed at drug development in the pediatric field have not been focused significantly. There are different regulatory bodies that administrate the pediatric regulations for a particular region.
Background: Paroxetine hydrochloride hemihydrate (PHH) is a serotonin reuptake inhibitor useful for the treatment of diverse psychiatric problems. Existing marketed formulations with frequent administration lead to gastrointestinal (GI) reactions and abrupt fluctuations in plasma level with poor patient compliance. These prerequisites are sufficed by controlled release push-pull osmotic pump tablets (PPOP). Objective: Objective of the present study was to develop robust and reliable PPOP formulation via Quality by design (QbD) approach to achieve desired release kinetics. Methods: PPOP was formulated using wet granulation method followed by osmotic coating. QbD strategy for defining the risk assessment of influential variables such as swelling polymers and osmogen on in vitro release kinetics of designed PPOP. Results: Presence of Polyox in push and pull layer along with osmogen controlled the drug release pattern from formulated PPOP system as depicted in 33 factorial design. These formulated optimized PPOP systems demonstrated 2 hrs lag time with zero-order kinetics, a peculiar feature of PPOPs. Conclusions: Scalable, stable PPOP tablets were fabricated by applying systematic QbD approach. The developed PPOP systems with improved concentration-independent behavior helped to address the challenges of existing marketed formulations. Risk mitigation and control strategy assured quality of the system during scalability. Application of QbD strategy in establishing the PPOP formulation would help in formulating drug candidates having gastric limitations and poor patient compliance. The present study is the detailed account of QbD based PPOP formulation, therefore it can be of potential importance from academics as well as industrial perspective.
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