Implementation of Quality by Design principles for the evolution of optimized sustained release drug delivery system

2021 ◽  
Vol 11 ◽  
Author(s):  
Lalit Singh ◽  
Vijay Sharma
Keyword(s):  
Mathematical Model ◽  
Drug Delivery ◽  
Sustained Release ◽  
Drug Delivery System ◽  
Delivery System ◽  
Dosage Form ◽  
Quality By Design ◽  
Design Principles ◽  
Release Drug

Aim: Aim of the present work is implementation of Quality by Design principles for the evolution of optimized sustained release drug delivery system Background: Quality by Design (QbD) approach refers to an advance approach to develop a optimized dosage form.QbD has become a vital modern scientific approach to develop a quality dosage form.In modern era of science researcher can develop a optimized dosage form with least effort, money and manpower. Objectives: Objective of research work wasthe successful development of optimized floating bioadhesive tablets of glipizide using floating-bioadhesive potential of cellulosic polymer and carbomersusing quality by design (QbD) approach. Method: Quality Target Product Profile (QTPP) of drug delivery system was defined as well as critical quality attributes (CQAs) were identified. A face centered central composite design (CCD) was utilized in assessing the impact of individual critical material attribute (CMA) like Hydro Propyl Methyl Cellulose K4M(HPMC K4M)and Carbopol 934P (CP 934P) and their interactions, using least experimentation. Formulations were developed and quantitative impact on CQAs was determined using mathematical model. The optimized formulation was obtained and characterized for in-vitro as well as in-vivo parameters. Results: A Fishikawa diagram and Failure Mode and Effect Analysis (FMEA) were performed to identify potential failure modes associated with the dosage form. The optimum formulation was embarked upon using mathematical model developed yielding desired CQAs followed for confirmation of data. Sustained release drug delivery system was successfully developed by using QbD approach. In-vivo X-ray imaging in rabbit and γ-scintigraphic study in manconfirmed the buoyant nature of the mucoadhesive floating tablet for 8 h in the upper gastrointestinal tract. Conclusion: Optimized formulation shows phenomenal floating, bioadhesive properties and drug release retardation characteristics, utilizing a mixture of cost-effective polymers Hence, QbD approach may be regarded as an important tool in development of floating bioadhesive CR dosage forms.

Design and preparation acid-activated montmorillonite sustained-release drug delivery system for dexibuprofen in vitro and in vivo evaluations

2018 ◽  
Vol 163 ◽  
pp. 178-185 ◽  
Author(s):  
Tingting Li ◽  
Lele Zhao ◽  
Ziliang Zheng ◽  
Min Zhang ◽  
Yidan Sun ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Sustained Release ◽  
Drug Delivery System ◽  
Delivery System ◽  
Release Drug

SELF-EMULSIFYING DRUG DELIVERY SYSTEM CONTAINING ACECLOFENAC: DESIGN & DEVELOPMENT USING QUALITY BY DESIGN (QBD) CONCEPT

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (06) ◽  
pp. 16-26
Author(s):  
V Suthar ◽  
◽  
M Gokel ◽  
S Butani ◽  
A Solanki
Keyword(s):  
Drug Delivery ◽  
Drug Delivery System ◽  
Delivery System ◽  
Dosage Form ◽  
Quality By Design ◽  
Tween 80 ◽  
Current Approach ◽  
In Vitro Dissolution ◽  
Design Development

The aim of the present study was to develop self-emulsifying drug delivery system (SEDDS) of aceclofenac for potential improvement in the in vitro dissolution. The Food and Drug Control Agency (FDCA) has put more stress on the quality, safety and efficacy of the dosage form. The use of design of experiments and quality by Design (QbD) in the development of self emulsifying drug delivery system (SEDDS) containing aceclofenac is demonstrated. The optimum formulation contained Labrafil M 1944 CS, Tween 80 and Transcutol P. The systematic approach enabled us in identifying the design space. The results revealed that while devising the control strategies during manufacturing, more attention should be focused on the ratios of oil to surfactant and surfactant to co-surfactant. The drug was released at a faster rate due to a large surface area. The current approach enabled us to develop a dosage form which is economic, patient-friendly and does not require assistance of a doctor or nurse, especially at remote places at odd hours.

Supramolecular micellar drug delivery system based on multi-arm block copolymer for highly effective encapsulation and sustained-release chemotherapy

2019 ◽  
Vol 7 (37) ◽  
pp. 5677-5687 ◽  
Author(s):  
Li Zhang ◽  
Dongjian Shi ◽  
Chunling Shi ◽  
Tatsuo Kaneko ◽  
Mingqing Chen
Keyword(s):  
Drug Delivery ◽  
Block Copolymer ◽  
Sustained Release ◽  
Drug Delivery System ◽  
Delivery System ◽  
Drug Loading ◽  
High Drug ◽  
Release Drug ◽  
Drug Loading Efficiency ◽  
High Drug Loading

A novel multi-arm polyphosphoester-based nanomaterial provides high drug loading efficiency and sustained-release drug delivery for effective chemotherapy.

Gastro-retentive drug delivery system for treatment of Ulcer

2019 ◽  
Vol 3 (02) ◽  
pp. 203-210
Author(s):  
Mohd Vaseem Fateh ◽  
Vikas Kumar ◽  
Renu Chaudhary ◽  
Vivak Ujjwal
Keyword(s):  
Drug Delivery ◽  
Drug Release ◽  
Sustained Release ◽  
Drug Delivery System ◽  
Delivery System ◽  
Drug Concentration ◽  
Oral Dosage ◽  
Oral Drug ◽  
Time Duration ◽  
Release Drug

Due to the comfort of administration, economical and extensibility in formulation, the most adopted route to the systemic circulation is the oral route regardless of the astounding elevation in the drug delivery. Oral drug delivery is the most comforting method of delivery due to its comforting method of delivery, due to its better solubility, accurate dosage and simpler production. Approximately 90% of the drugs are administered orally of which solid oral dosage form is the most chosen class of medicaments. Conventional dosage forms usually exhibit the serum drug concentration fluctuations and irregularities in drug concentration in the tissues with resultant toxicity, low bioavailability and thus low therapeutic effects. Accordingly, the concept of the oral sustained release drug delivery system has gained popularity in advancement. Sustained release drug deliveries have steady and consistent drug release over longer time duration. Here, if the drug release is consistent over the time duration, it is supposed to be controlled release system, however if the system doesn’t achieve the constant drug release but shows the drug release over the longer duration compared to the conventional system, it is prolonged release systems. These systems are hot in the recent trend as they offer huge designing and adaptability range during formulation

pH-responsive and sustained release drug delivery system of BSA coated CDs-DOX

2021 ◽  
pp. 131358
Author(s):  
Qianqian Duan ◽  
Jiaying Shi ◽  
Lan Zhou ◽  
Boye Zhang ◽  
Xiaoyuan Wang ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Sustained Release ◽  
Drug Delivery System ◽  
Delivery System ◽  
Ph Responsive ◽  
Release Drug
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