Quality by Design enabled the development of stable and effective oil-in-water emulsions at compounding pharmacy: the case of a sunscreen formulation

Leishmaniasis is one of the most neglected diseases in the world. Its most severe clinical form, called visceral, if left untreated, can be fatal. Conventional therapy is based on the use of pentavalent antimonials and includes amphotericin B (AmB) as a second-choice drug. The micellar formulation of AmB, although effective, is associated with acute and chronic toxicity. Commercially-available lipid formulations emerged to overcome such drawbacks, but their high cost limits their widespread use. Drug delivery systems such as nanoemulsions (NE) have proven ability to solubilize hydrophobic compounds, improve absorption and bioavailability, increase efficacy and reduce toxicity of encapsulated drugs. NE become even more attractive because they are inexpensive and easy to prepare. The aim of this work was to incorporate AmB in NE prepared by sonicating a mixture of surfactants, Kolliphor® HS15 (KHS15) and Brij® 52, and an oil, isopropyl myristate. NE exhibited neutral pH, conductivity values consistent with oil in water systems, spherical structures with negative Zeta potential value, monomodal size distribution and average diameter of drug-containing droplets ranging from 33 to 132 nm. AmB did not modify the thermal behavior of the system, likely due to its dispersion in the internal phase. Statistically similar antileishmanial activity of AmB-loaded NE to that of AmB micellar formulation suggests further exploring them in terms of toxicity and effectiveness against amastigotes, with the aim of offering an alternative to treat visceral leishmaniasis.

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Implementation of “Quality by Design (QbD)” Approach for the Development of 5-Fluorouracil Loaded Thermosensitive Hydrogel

Current Drug Delivery ◽

10.2174/1567201812666150817122506 ◽

2016 ◽

Vol 13 (4) ◽

pp. 512-527 ◽

Cited By ~ 2

Author(s):

Chintan Dalwadi ◽

Gayatri Patel

Keyword(s):

Quality By Design ◽

Thermosensitive Hydrogel

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Preparation and Optimization of Moxifloxacin Microspheres for Colon Targeted Delivery Using Quality by Design Approach: In Vitro and In Vivo Study

Current Drug Delivery ◽

10.2174/1567201813666160512145625 ◽

2016 ◽

Vol 13 (7) ◽

pp. 1021-1033 ◽

Cited By ~ 4

Author(s):

Bhumika Prajapati ◽

Prasant Kumar Jena ◽

Tejal Mehta ◽

Sriram Seshadri

Keyword(s):

Targeted Delivery ◽

Quality By Design ◽

Design Approach ◽

In Vivo Study ◽

Quality By Design Approach

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Quality by Design: Concept to Applications

Current Drug Discovery Technologies ◽

10.2174/1570163815666180308142016 ◽

2019 ◽

Vol 16 (3) ◽

pp. 240-250 ◽

Cited By ~ 2

Author(s):

Suryakanta Swain ◽

Rabinarayan Parhi ◽

Bikash Ranjan Jena ◽

Sitty Manohar Babu

Keyword(s):

Quality By Design ◽

Pharmaceutical Products ◽

Assessment Tools ◽

Basic Knowledge ◽

Target Product ◽

Target Product Profile ◽

Critical Material ◽

Novel Approach ◽

Product Profile ◽

Performance Report

Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

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Nanoemulsions- A better Approach for Anti Diabeticdrugs Delivering

Current Diabetes Reviews ◽

10.2174/1573399817666201209095205 ◽

2020 ◽

Vol 17 ◽

Author(s):

V. Manimaran ◽

Ponnurengam Malliappan Sivakumar ◽

J. Narayanan ◽

Shanmugam Parthasarathi ◽

Pranav Kumar Prabhakar

Keyword(s):

Aqueous Phase ◽

Therapeutic Agent ◽

Antidiabetic Drugs ◽

Optical Behaviour ◽

Antimicrobial Drugs ◽

Drug Degradation ◽

Oil In Water ◽

Drug Technology ◽

Human Use ◽

Poor Absorption

: Conventional delivery of antidiabetic drugs faces many problems like poor absorption, low bioavailability, and drug degradation. Nanoemulsion is a unique drug technology which is very suitable for the delivery of antidiabetic drugs. In recent years the flaws of delivering anti-hypoglycaemic drugs have been overcome by choosing nanoemulsion drug technology. They are thermodynamically stable and also deliver the therapeutic agent for a longer duration. Generally, Nanoemulsions are made up of either oil-in-water or water-in-oil and size of the droplets is from fifty to thousand nanometer. Surfactants are critical substances which are added in the manufacturing of nanoemulsions. Only the surfactants which are approved for human use can be utilized in the manufacturing of nanoemulsions. Generally, the preparation of emulsions includes mixing of the aqueous phase and organic phase and using surfactant with proper agitation. Nanoemulsions are used for antimicrobial drugs, and they are also used in the prophylaxis of cancer, diabetics. Reduction in the droplet size may cause variation in the elastic and optical behaviour of nanoemulsions.

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