Match!

Relationships between response surfaces for tablet characteristics of placebo and API-containing tablets manufactured by direct compression method

Published on Oct 1, 2017in International Journal of Pharmaceutics4.213
· DOI :10.1016/j.ijpharm.2017.08.111
Yoshihiro Hayashi7
Estimated H-index: 7
(University of Toyama),
Takahiro Tsuji1
Estimated H-index: 1
(University of Toyama)
+ 6 AuthorsYoshinori Onuki15
Estimated H-index: 15
(University of Toyama)
Abstract
Abstract In this study, we evaluated the correlation between the response surfaces for the tablet characteristics of placebo and active pharmaceutical ingredient (API)-containing tablets. The quantities of lactose, cornstarch, and microcrystalline cellulose were chosen as the formulation factors. Ten tablet formulations were prepared. The tensile strength (TS) and disintegration time (DT) of tablets were measured as tablet characteristics. The response surfaces for TS and DT were estimated using a nonlinear response surface method incorporating multivariate spline interpolation, and were then compared with those of placebo tablets. A correlation was clearly observed for TS and DT of all APIs, although the value of the response surfaces for TS and DT was highly dependent on the type of API used. Based on this knowledge, the response surfaces for TS and DT of API-containing tablets were predicted from only two and four formulations using regression expression and placebo tablet data, respectively. The results from the evaluation of prediction accuracy showed that this method accurately predicted TS and DT, suggesting that it could construct a reliable response surface for TS and DT with a small number of samples. This technique assists in the effective estimation of the relationships between design variables and pharmaceutical responses during pharmaceutical development.
  • References (29)
  • Citations (1)
📖 Papers frequently viewed together
1 Citations
2014
4 Authors (Neha Kanuja, ..., Rajni Bala)
51 Citations
78% of Scinapse members use related papers. After signing in, all features are FREE.
References29
Newest
#1Sanjay Bansal (Maharishi Markandeshwar University, Mullana)H-Index: 2
#2Sarwar Beg (Panjab University, Chandigarh)H-Index: 20
Last. Bhupinder Singh (Panjab University, Chandigarh)H-Index: 29
view all 6 authors...
The objective of the present studies was systematic development of floating-bioadhesive gastroretentive tablets of cefuroxime axetil employing rational blend of hydrophilic polymers for attaining controlled release drug delivery. As per the QbD-based approach, the patient-centric target product profile and quality attributes of tablet were earmarked, and preliminary studies were conducted for screening the suitability of type of polymers, polymer ratio, granulation technique, and granulation tim...
5 CitationsSource
#1Parind Mahendrakumar Desai (NUS: National University of Singapore)H-Index: 6
#2Celine Valeria Liew (NUS: National University of Singapore)H-Index: 18
Last. Paul Wan Sia Heng (NUS: National University of Singapore)H-Index: 37
view all 3 authors...
Disintegrant is one of the most important components in a typical tablet dosage form. It is responsible for ensuring the break-up of the tablet matrix upon ingestion. Disintegrants act by different mechanisms, and a number of factors may affect their performance. It is important for formulators to understand how disintegrants function so as to be able to judiciously use disintegrants to develop optimized formulations. If the formulator is required to implement the quality by design paradigm whil...
53 CitationsSource
#1Cosima Hirschberg (UCPH: University of Copenhagen)H-Index: 3
#2Changquan Calvin Sun (UMN: University of Minnesota)H-Index: 30
Last. Jukka Rantanen (UCPH: University of Copenhagen)H-Index: 44
view all 3 authors...
Abstract Characterization of particulate systems (powders) is one of the remaining scientific challenges. Evaluation of powder behaviour is often empirical and the decision-making processes are experience-based. There is a need for development of analytical instrumentation enabling more fundamental understanding of powder behaviour. Flowability and tabletability, two key factors in commercial scale manufacturing of tablets with direct compression (DC) approach, were analysed for formulations con...
12 CitationsSource
#1K. Pramod (Government Medical College, Thiruvananthapuram)H-Index: 8
#2MAbu TahirH-Index: 1
Last. Javed Ali (Jamia Hamdard)H-Index: 43
view all 5 authors...
The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls sect...
30 CitationsSource
In this work, we have quantified effects of moisture content, over the relative humidity (RH) range of 5–92% corresponding to 1.6–10.9% of water content, on flow properties of a grade of microcrystalline cellulose (Avicel PH102) using a ring shear cell. Several key powder flow parameters, including cohesion (τc), unconfined yield strength (fc), powder bulk density (ρb), flowability (ffc), and effective angle of internal friction (ϕe), were assessed. Powder flow properties deteriorated continuous...
37 CitationsSource
The primary drug quality requirements—safety, efficacy, and reliability—for oral pharmaceutical products in tablet form, translate into bioavailability, tablet weight, and tablet strength. The bioavailability of an oral drug, i.e., the amount of the drug that can reach the systemic circulation, is dependent on the drug permeation rate through the epithelial membrane or on dissolution rate, in the case of bioequivalence. Thus, the critical quality attributes affecting bioavailability can be the d...
5 CitationsSource
#1Hiromi BabaH-Index: 4
#2Jun-ichi TakaharaH-Index: 2
Last. Hiroshi Mamitsuka (Kyoto University)H-Index: 28
view all 3 authors...
Purpose Predicting human skin permeability of chemical compounds accurately and efficiently is useful for developing dermatological medicines and cosmetics. However, previous work have two problems; 1) quality of databases used, and 2) methods for prediction models. In this paper, we attempt to solve these two problems.
19 CitationsSource
#1Michael M. Leane (BMS: Bristol-Myers Squibb)H-Index: 6
#2Kendal G. Pitt (GSK: GlaxoSmithKline)H-Index: 5
Last. Gavin K. Reynolds (AstraZeneca)H-Index: 18
view all 3 authors...
AbstractThis paper proposes the development of a drug product Manufacturing Classification System (MCS) based on processing route. It summarizes conclusions from a dedicated APS conference and subsequent discussion within APS focus groups and the MCS working party. The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the API and the needs of the formulatio...
78 CitationsSource
#1Sureewan Duangjit (SU.: Silpakorn University)H-Index: 8
#2Leilah Maria Mehr Leilah Maria Mehr (SU.: Silpakorn University)H-Index: 1
Last. Tanasait Ngawhirunpat (SU.: Silpakorn University)H-Index: 28
view all 4 authors...
15 CitationsSource
#1Tianfeng Chai (UMD: University of Maryland, College Park)H-Index: 24
#2Roland R. Draxler (Air Resources Laboratory)H-Index: 29
Abstract. Both the root mean square error (RMSE) and the mean absolute error (MAE) are regularly employed in model evaluation studies. Willmott and Matsuura (2005) have suggested that the RMSE is not a good indicator of average model performance and might be a misleading indicator of average error, and thus the MAE would be a better metric for that purpose. While some concerns over using RMSE raised by Willmott and Matsuura (2005) and Willmott et al. (2009) are valid, the proposed avoidance of R...
812 CitationsSource
Cited By1
Newest
Abstract In the pharmaceutical industry, the systematic optimization of formulation using Quality by Design (QbD) approach is economic, highly precise and ensures product quality. The current endeavor was aimed to prepare escitalopram ultra-fast melting tablets (UFMTs) based on QbD approach using suspension spray-coating technique. The (32) full factorial design was applied to obtain the optimal formulation in terms of; mannitol level (X1) and partially pre-gelatinized starch level (PPGS; X2) as...
Source
#1Takuya Oishi (University of Toyama)H-Index: 1
#2Yoshihiro Hayashi (University of Toyama)H-Index: 7
Last. Yoshinori Onuki (University of Toyama)H-Index: 15
view all 8 authors...
Abstract Our aim was to understand better the causal relationships between material attributes (MAs), process parameters (PPs), and critical quality attributes (CQAs) using an originally created large dataset and regularized linear regression models. In this study, we focused on the following three points: (1) creation of a dataset comprising several tablet production methods, (2) the influence of interaction terms of MAs and/or PPs, and (3) comparison of regularized linear regression models wit...
Source
#1Masoud TayefiH-Index: 3
Last. Alireza SabetH-Index: 3
view all 3 authors...
Source
#1Sureewan Duangjit (Ubon Ratchathani University)H-Index: 8
#2Pakorn Kraisit (Thammasat University)H-Index: 3
Abstract The objective of this study was focused on the optimization of the pharmaceutical excipients and banana extract in the preparation of orally disintegrating banana extract tablets (OD-BET) and conventional banana extract tablets (CO-BET) using a simplex lattice design. Various ratios of banana extract (BE), dibasic calcium phosphate (DCP) and microcrystalline cellulose (MCC) were used to prepare banana extract tablets (BET). The results indicated that the optimal OD-BET and CO-BET consis...
1 CitationsSource