scholarly journals Biopharmaceutical Classification System in Invitro/ In-vivo Correlation: Concept and Development Strategies in Drug Delivery

2012 ◽  
Vol 11 (2) ◽  
Author(s):  
S Nainar ◽  
K Rajiah ◽  
S Angamuthu ◽  
D Prabakaran ◽  
R Kasibhatta
Keyword(s):  
Drug Delivery ◽  
Classification System ◽  
Development Strategies ◽  
Biopharmaceutical Classification System

scholarly journals Profil Laju Disolusi Kokristal Simvastatin Menggunakan Koformer Aspartam, Nikotinamid, dan Sakarin

2020 ◽  
Vol 4 ◽  
Author(s):  
Dolih Gozali ◽  
Popy Sarah Chairunnisa ◽  
Iyan Sopyan
Keyword(s):  
Classification System ◽  
Biopharmaceutical Classification System

Simvastatin merupakan obat golongan HMG-CoA reduktase inhibitor yang banyak diberikan pada pasien sebagai obat antikolesterol. Kelarutannya yang rendah dalam air dan permeabilitas yang tinggi menyebabkan rendahnya bioavaibilitas sehingga simvastatin tergolong kedalam obat kelas II berdasarkan Biopharmaceutical Classification System (BCS). Skrining penggunaan koformer pada pembentukan kokristal simvastatin dengan 12 koformer menunjukkan pengaruh signifikan pada peningkatan kelarutan dan uji disolusi. Kokristal yang memiliki profil kelarutan dan disolusi terbaik adalah kokristal simvastatin:aspartam (KKA), simvastatin:nikotinamid (KKN), dan simvastatin:sakarin (KKS). Salah satu instrumen spesifik yang dapat digunakan untuk karakterisasi fase padat suatu obat yang telah dimodifikasi adalah evaluasi disolusi. Kokristal KKA, KKN, KKS diuji lanjut dengan disolusi intrinsik dan disolusi-absorpsi in vitro. Metode Disolusi-Absorpsi in vitro dilakukan untuk melihat laju penyerapan obat dan sebagai langkah awal pendekatan uji bioavaibilitas secara in vivo. Kokristal KKN dan KKS secara signifikan meningkatkan laju disolusi intrinsik simvastatin sebanyak 9 dan 21 kalinya. Laju disolusi-absorpsi in vitro simvastatin secara signifikan meningkat pada KKS hingga 9 kali zat murninya.

FORMULATION AND EVALUATION OF LIPID BASED SELF EMULSIFYING DRUG DELIVERY SYSTEM OF GLIMEPIRIDE

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (11) ◽  
pp. 48-51
Author(s):  
K Sneha Latha ◽  
◽  
G. B Kiran Kumar ◽  
G. A Mohammed ◽  
S.K Chowdary ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Oleic Acid ◽  
Drug Release ◽  
Dissolution Rate ◽  
Drug Delivery System ◽  
Delivery System ◽  
Classification System ◽  
Tween 80 ◽  
Low Solubility ◽  
Biopharmaceutical Classification System

Aim of the present investigation was to develop lipid based self-emulsifying drug delivery system (SEDDS) to improve bioavailability of glimepiride. Glimepiride is a class II molecule according to BCS (Biopharmaceutical Classification System), having low solubility. Optimized self-emulsifying drug delivery system of glimepiride comprising oil (oleic acid), surfactant (Tween 80®) and co-surfactant (PEG 200®) was prepared. Optimized SEDDS of glimepiride showed increase in dissolution rate. It was concluded that the formulation was found to be showing significant improvement in terms of the drug release with complete release of drug within 18 minutes. Thus, self-emulsifying formulation of glimepiride was successfully developed.

In vitro -in vivo correlation and biopharmaceutical classification system

2011 ◽  
Vol 2 (3) ◽  
pp. 126
Author(s):  
G Tiwari ◽  
B Srivastawa ◽  
S Pandey ◽  
R Tiwari ◽  
AK Rai ◽  
...  
Keyword(s):  
Classification System ◽  
Biopharmaceutical Classification System

Pharmaceutical Drug Nanocrystals: Role in Dermal Delivery

2019 ◽  
Vol 9 (3) ◽  
pp. 300-310
Author(s):  
Manish Kumar ◽  
Nithya Shanthi ◽  
Arun Kumar Mahato
Keyword(s):  
Drug Delivery ◽  
Drug Administration ◽  
Classification System ◽  
Aqueous Solubility ◽  
Review Article ◽  
Pharmaceutical Drug ◽  
Dermal Delivery ◽  
Biopharmaceutical Classification System ◽  
Class Iv

Introduction: Nanocrystals constitutes of 100% drug and considered as a “new drug” by Food and Drug Administration. It is proven to be an effective alternative for topical delivery of drug with increased bioavailability. Recently formulation of the drug as nanocrystals has been accomplished for many drugs exhibiting low aqueous solubility, ineffective permeability or both in order to increase the dermal bioavailability. Conclusion: In this review article, an effort was made to explain the role of nanocrystals in the dermal delivery of the drug which results in increased bioavailability and efficacy through enhancement of solubility, dissolution velocity, permeation and penetration. Recently dermal delivery of the drug as nanocrystals is a challenging method but explained by many researchers through their work. Preparation of drugs as nanocrystals might be a promising method of drug delivery to Class II and Class IV drugs of Biopharmaceutical Classification System. Drug nanocrystals can also be applied in cosmetics for effective results.

scholarly journals Global testing of a consensus solubility assessment to enhance robustness of the WHO biopharmaceutical classification system

ADMET & DMPK ◽  
2020 ◽  
Author(s):  
Valeria Gigante ◽  
Giovanni M. Pauletti ◽  
Sabine Kopp ◽  
Minghze Xu ◽  
Isabel Gonzalez-Alvarez ◽  
...  
Keyword(s):  
Classification System ◽  
Global Network ◽  
Essential Medicines ◽  
Health Coverage ◽  
Pharmaceutical Ingredients ◽  
Fraction Absorbed ◽  
Practical Tool ◽  
Low Solubility ◽  
Biopharmaceutical Classification System

The WHO Biopharmaceutical Classification System (BCS) is a practical tool to identify active pharmaceutical ingredients (APIs) that scientifically qualify for a waiver of in vivo bioequivalence studies. The focus of this study was to engage a global network of laboratories to experimentally quantify the pH-dependent solubility of the highest therapeutic dose of 16 APIs using a harmonized protocol. Intra-laboratory variability was ≤5 %, and no apparent association of inter-laboratory variability with API solubility was discovered. Final classification “low solubility” vs “high solubility” was consistent among laboratories. In comparison to the literature-based provisional 2006 WHO BCS classification, three compounds were re-classified from “high” to “low-solubility”. To estimate the consequences of these experimental solubility results on BCS classification, dose-adjusted in silico predictions of the fraction absorbed in humans were performed using GastroPlus®. Further expansion of these experimental efforts to qualified APIs from the WHO Essential Medicines List is anticipated to empower regulatory authorities across the globe to issue scientifically-supported guidance regarding the necessity of performing in vivo bioequivalence studies. Ultimately, this will improve access to affordable generic products, which is a critical prerequisite to reach Universal Health Coverage.  

Acyclovir Loaded Solid Lipid Nanoparticle Based Cream: A Novel Drug Delivery System

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
EL- Assal I. A. ◽  
Retnowati .
Keyword(s):  
Drug Delivery ◽  
Drug Release ◽  
Antiviral Agent ◽  
Study Drug ◽  
Particle Size Analysis ◽  
Stability Study ◽  
Size Analysis ◽  
Solid Lipid ◽  
Dermal Delivery

Objective of the present investigation was enthused by the possibility to develop solid lipid nanoparticles (SLNs) of hydrophilic drug acyclovir. Also study vitro and vivo drug delivery. Methods: Drug loaded SLNs (ACV-SLNs) were prepared by high pressure homogenization of aqueous surfactant solutions containing the drug-loaded lipids in the melted or in the solid state with formula optimization study (Different lipid concentration, drug loaded, homogenization / stirring speed and compritol 888ATO: drug ratio). ACV - SLN incorporated in cream base. The pH was evaluated and rheological study. Drug release was evaluated and compared with simple cream- drug, ACV – SLN with compritol 888ATO and marketed cream. The potential of SLN as the carrier for dermal delivery was studied. Results: Particle size analysis of SLNs prove small, smooth, spherical shape particle ranged from 150 to 200 nm for unloaded and from 330 to 444 nm for ACV loaded particles. The EE% for optimal formula is 72% with suitable pH for skin application. Rheological behavior is shear thinning and thixotropic. Release study proved controlled drug release for SLNs especially in formula containing compritol88 ATO. Stability study emphasized an insignificant change in SLNs properties over 6 month. In-vivo study showed significantly higher accumulation of ACV in stratum corneum, dermal layer, and receptor compartment compared with blank skin. Conclusion: AVC-loaded SLNs might be beneficial in controlling drug release, stable and improving dermal delivery of antiviral agent(s).

Development and Evaluation of Floating Pulsatile Drug Delivery System Using Meloxicam

2017 ◽  
Vol 7 (04) ◽  
Author(s):  
ShirishaG. Suddala ◽  
S. K. Sahoo ◽  
M. R. Yamsani
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Delivery ◽  
Drug Release ◽  
Drug Delivery System ◽  
Delivery System ◽  
Lag Time ◽  
Oral Dosage ◽  
Lag Phase ◽  
Pulsatile Drug Delivery

Objective: The objective of this research work was to develop and evaluate the floating– pulsatile drug delivery system (FPDDS) of meloxicam intended for Chrono pharmacotherapy of rheumatoid arthritis. Methods: The system consisting of drug containing core, coated with hydrophilic erodible polymer, which is responsible for a lag phase for pulsatile release, top cover buoyant layer was prepared with HPMC K4M and sodium bicarbonate, provides buoyancy to increase retention of the oral dosage form in the stomach. Meloxicam is a COX-2 inhibitor used to treat joint diseases such as osteoarthritis and rheumatoid arthritis. For rheumatoid arthritis Chrono pharmacotherapy has been recommended to ensure that the highest blood levels of the drug coincide with peak pain and stiffness. Result and discussion: The prepared tablets were characterized and found to exhibit satisfactory physico-chemical characteristics. Hence, the main objective of present work is to formulate FPDDS of meloxicam in order to achieve drug release after pre-determined lag phase. Developed formulations were evaluated for in vitro drug release studies, water uptake and erosion studies, floating behaviour and in vivo radiology studies. Results showed that a certain lag time before drug release which was due to the erosion of the hydrophilic erodible polymer. The lag time clearly depends on the type and amount of hydrophilic polymer which was applied on the inner cores. Floating time and floating lag time was controlled by quantity and composition of buoyant layer. In vivo radiology studies point out the capability of the system of longer residence time of the tablets in the gastric region and releasing the drug after a programmed lag time. Conclusion: The optimized formulation of the developed system provided a lag phase while showing the gastroretension followed by pulsatile drug release that would be beneficial for chronotherapy of rheumatoid arthritis and osteoarthritis.

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