Formulation development and evaluation of a novel bi-dependent clarithromycin gastroretentive drug delivery system using Box-Behnken design

Malladi, Madhusudhan; Jukanti, Raju

doi:10.1016/j.jddst.2016.06.003

Cited by 16 publications

(7 citation statements)

References 39 publications

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“…DoE has been used extensively in the optimization of chemical processes, particularly in pharmaceutical and fine chemical settings. DoE is often used for studies relating to enhancing the yield − and purity − of particular products but is also used for drug formulations − and delivery, − analytical method development, − and more. − This is because there are numerous and undisputed benefits to the use of DoE for experimental parameter screening and optimization, especially when compared with traditional human intuition-guided experimentation. With the rise of user-friendly software packages and the increased awareness of the chemical community, there has been a large uptake of this statistical method in recent years, although the technique itself has been around since the mid-20th century .…”

Section: Design Of Experiments (Doe)mentioning

confidence: 99%

A Brief Introduction to Chemical Reaction Optimization

et al. 2023

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From the start of a synthetic chemist’s training, experiments are conducted based on recipes from textbooks and manuscripts that achieve clean reaction outcomes, allowing the scientist to develop practical skills and some chemical intuition. This procedure is often kept long into a researcher’s career, as new recipes are developed based on similar reaction protocols, and intuition-guided deviations are conducted through learning from failed experiments. However, when attempting to understand chemical systems of interest, it has been shown that model-based, algorithm-based, and miniaturized high-throughput techniques outperform human chemical intuition and achieve reaction optimization in a much more time- and material-efficient manner; this is covered in detail in this paper. As many synthetic chemists are not exposed to these techniques in undergraduate teaching, this leads to a disproportionate number of scientists that wish to optimize their reactions but are unable to use these methodologies or are simply unaware of their existence. This review highlights the basics, and the cutting-edge, of modern chemical reaction optimization as well as its relation to process scale-up and can thereby serve as a reference for inspired scientists for each of these techniques, detailing several of their respective applications.

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Section: Design Of Experiments (Doe)mentioning

confidence: 99%

A Brief Introduction to Chemical Reaction Optimization

et al. 2023

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“…The main experimental approaches used for oral DDS optimization are compared in Table 3, along with their advantages and disadvantages. Full factorial designs (FDs), including two-level and three-level FDs, fractional factorial designs (CCD), Box-Behnken designs (BBD), Plackett-Burman designs (PBD), Taguchi methods, and mixture designs, are among the several types of experimental designs (Figure 3) [19].…”

Section: Experimental Designs Used During Fbd Of Oral Ddsmentioning

confidence: 99%

Formulation by Design: An Overview

Das¹,

Panda²,

Mandal³

2023

Drug Formulation Design

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Quality is the most important and necessary attribute for pharmaceutical product development, and it has become the focus of regulatory bodies in order to approve safe, efficacious, stable, patient-compliance, and cost-effective drug delivery systems. QbD-based formulation development is discovered to be an immerging technique in this context. FbD is a formulation development concept that aims to create more effective, safe, robust, cost-effective, and patient-compliant drug delivery systems. This chapter will provide an overview of Formulation by Design (FbD), different terminologies, design of experiment (DoE) and quality by design (QbD), types of experimental design, QbD applications, and FbD methodology along with benefits.

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“…Malladi and Jukanti have developed clarithromycin matrix tablets based on HPMC K4M, which float due to the presence of pores formed during the sublimation of camphor introduced into the composition. The optimized DF had a zero rise time delay of 10 s, a flotation time of more than 12 h, and a delayed release of API [55].…”

Section: Hpmcmentioning

confidence: 99%

“…Hollow granules (ionotropic gelation) Chitosan [25] Granules (ionotropic gelation) NA, Carrageenan [28] NA, Eudragit RL100 [85] Chitosan [26] Pectin [30] NA conjugate with bovine serum albumin [37] Hollow microspheres (solvent removal) EC [47] EC, HPMC E5 [50] EC, HPMC E50 [86] Eudragit S-100 [71] Eudragit S-100 [72] Acrycoat S 100 [74] Combination of Eudragit L100 and Eudragit RS100 [73] Polycarbonate, Polypropylene Glycol PFA [83] HPMC 3K, Eudragit RS PO [87] EC (10 cP), PVP [88] Microspheres (solvent removal) EC [89] EC, HPMC K4M [90] CA [62] Microspheres ("multiple emulsion method", solvent removal) EC, PVP [91] Tablets (direct compression) HPMC K4M, Camphor SA [55] Tablets (wet granulation) Locust bean gum, Camphor SA [41] HPC (Klucel LF), PEO (Polyox WSR N 60 K), Menthol SA [92] Tablets (shaping and freeze drying) EC, HPMC (100 cP) [49] Tablets (FDM 3D printing) HPC [60] HPMC acetate succinate, PEG 400 [93] HPC, PVP [94] Tablets (Tablet-core-direct compression; body-FDM 3D printing) HPC, EC [59] PLA [81] EVOH, HPMC K15M [65] Tablets (SLS 3D printing) Nylon [82] Cylindrical extrudate (3D printing with simultaneous ionotropic gelation) NA [23] Hydrogel (ionotropic gelation) Graft copolymer of chitosan and PVP [27] Nanofiber (electrospinning) PLA [64] Pellets or cylindrical extrudates (extrusion) Eudragit RSPO, HPMC K15 M, Ethanol PFA [95] Modular gastro-renal delivery system (wet granulation and compression) HPMC K15 M, PEG 6000, PVP K30…”

Section: Air Incorporationmentioning

confidence: 99%

Polymeric Excipients in the Technology of Floating Drug Delivery Systems

Blynskaya

Tishkov²,

Vinogradov³

et al. 2022

Pharmaceutics

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The combination of targeted transport and improvement of the release profile of the active pharmaceutical ingredient (API) is a current trend in the development of oral medicinal products (MP). A well-known way to implement this concept is to obtain floating gastroretentive delivery systems that provide a long stay of the dosage form (DF) on the surface of the stomach contents. The nomenclature of excipients (Es) of a polymeric nature used in the technology of obtaining floating drug delivery systems (FDDS) is discussed. Based on the data presented in research papers, the most widely used groups of polymers, their properties, and their purpose in various technological approaches to achieving buoyancy have been determined. In addition, ways to modify the release of APIs in these systems and the Es used for this are described. The current trends in the use of polymers in the technology of floating dosage forms (FDF) and generalized conclusions about the prospects of this direction are outlined.

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Formulation development and evaluation of a novel bi-dependent clarithromycin gastroretentive drug delivery system using Box-Behnken design

Cited by 16 publications

References 39 publications

A Brief Introduction to Chemical Reaction Optimization

A Brief Introduction to Chemical Reaction Optimization

Formulation by Design: An Overview

Polymeric Excipients in the Technology of Floating Drug Delivery Systems

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