Formulation and Manufacturing of Solid Dosage Forms

Zhou, Qi Tony; Li, Tonglei

doi:10.1007/s11095-018-2547-6

Cited by 9 publications

(7 citation statements)

References 18 publications

(15 reference statements)

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“…Bulk and tapped densities were used for the calculation of Carr's index and Hausner's ratio [25][26]. For the determination of true density (ρ t ), xylene displacement method was used with equation (1). Tablet true density (ρ t ) was computed as the weighted average of the component true densities.…”

Section: Determination Of Size Distribution Densitymentioning

confidence: 99%

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Optimization of Pregelatinized Taro Boloso‐I Starch as a Direct Compression Tablet Excipient

Balla

Joseph

Belete

2023

BioMed Research International

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Background. Tablets are still the most preferred means of drug delivery. The search for new and improved direct compression tablet excipients is an area of research focus. This is because the direct compression method overcomes the drawbacks of granulation methods of tablet production. It exempts several treatment steps associated with the granulation methods. The requirements for the powders to be directly compressible include flowability, low friction tendency, compressibility, and fast disintegration capacity. Taro Boloso-I is a new variety of Colocasia esculenta (L. Schott) yielding 67% more than a previously reported variety (Godare) in Ethiopia. This study is aimed at enhancing the flowability while keeping the compressibility and compactibility of the pregelatinized Taro Boloso-I starch. Methods. Central composite design was used for the optimization of two factors which were the temperature and duration of pregelatinization against 4 responses. The responses were angle of repose, Hausner’s ratio, Heckel’s yield pressure, and tablet breaking force. Results and Discussions. An increase in the temperature resulted in decrease in both the angle of repose and the Hausner ratio and that of time decreased angle of repose as well. The Heckel yield pressure was observed to increase with increasing levels of both temperature and time. The pregelatinized starch prepared by heating 15% slurry of Taro Boloso-I starch at the pregelatinization temperature of 66.22°C for 20 min showed desired flow property and compressibility. Conclusions. Pregelatinized Taro Boloso-I starch could be regarded as a potential direct compression excipient in terms of flowability, compressibility, and compactibility. The PGTBIS could perform better as filler and binder in direct compression tablets than the Starch 1500® in terms of compactibility.

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Section: Determination Of Size Distribution Densitymentioning

confidence: 99%

“…Solid dosage forms, especially tablets, are still the most preferred means of drug delivery [1,2]. The search for new and improved direct compression tablet excipients is an area of research focus.…”

Section: Introductionmentioning

confidence: 99%

Optimization of Pregelatinized Taro Boloso‐I Starch as a Direct Compression Tablet Excipient

Balla

Joseph

Belete

2023

BioMed Research International

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“…While there are several types of pharmaceutical dosage forms, tablets are still the most preferred and the most commonly used option [ 1 , 2 ]. The direct compression method of tablet preparation is the most desirable method.…”

Section: Introductionmentioning

confidence: 99%

Comparative Direct Compression Property of a Novel Pregelatinized Starch in Paracetamol Tablets

Balcha Balla,

Mary Joseph,

Belete

2023

Advances in Pharmacological and Pharmaceutical Sciences

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Background. Among all the pharmaceutical dosage forms, tablets are still the most preferred and the most commonly used option because of their advantages. The direct compression method of tablet preparation exempts several steps needed in the granulation method. Therefore, the pursuit of better direct compression tablet excipients is evident in contemporary research endeavors. Pregelatinized Taro Boloso-I starch has comparable flow properties and higher compressibility and compactibility than Starch 1500®. However, there is no evidence in the literature regarding the lubricant sensitivity and dilution potential of pregelatinized Taro Boloso-I starch. This study was aimed at performing the in vitro evaluation of paracetamol tablets prepared using pregelatinized Taro Boloso-I starch as a direct compression excipient using paracetamol as a model drug. Methods. Taro Boloso-I starch was pregelatinized, and its properties including amylose to amylopectin ratio, densities, flow properties, swelling power, water solubility index, particle morphology, moisture content, and moisture sorption profile were evaluated. Furthermore, the lubricant sensitivity test, dilution potential study, and compatibility test with the paracetamol drug using ATR spectroscopy were performed. The properties of the directly compressed tablets prepared accordingly were evaluated. The majority of evaluations were performed in comparison with Starch 1500®. Results and Discussion. PGTBIS had a significantly lower amount of amylose than Starch 1500®. In the ATR-IR spectra of the mixture of the paracetamol and pregelatinized PGTBIS, all the major absorbance peaks of the drug were maintained indicating the absence of chemical modifications. PGTBIS showed better flow properties than Starch 1500®. The modified starch was shown to withstand magnesium stearate up to 0.5% concentration. Conclusion. PGTBIS could accommodate higher drug cargo than Starch 1500® with acceptable tablet properties. Accordingly, PGTBIS starch could be taken as a potential direct compression excipient.

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“…Second, the presence of partially neutralized acidic polymers in aqueous enteric coating formulations gives rise to higher swelling rates, on contact with gastric fluid, resulting in potential compromise of film acid-barrier function (Stafford and Ag 1982;B echard et al 1995;Thoma and Bechtold 1999). Interest in enteric formulations is sustained for a number of reasons, however primarily relates to protection offered from the harsh environment of the gastrointestinal tract and also the preference for solid dosage forms as the principal choice when formulating drug products (Zhou and Li 2018;Nemeth et al 2019). Thus far, there have been no literature reports of an enteric formulation, which is a true aqueous nanosuspension i.e.…”

Section: Introductionmentioning

confidence: 99%

Impact of nanosizing on the formation and characteristics of polymethacrylate films: micro- versus nano-suspensions

Yousaf

Isreb

Khan

et al. 2021

Pharmaceutical Development and Technology

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Aqueous-based film coating suspensions are associated with reliance on alkalinising reagents and poor film formation. The impact of particle size in this process and resultant film properties remains unclear. This study offers the first direct comparison of film formation properties between aqueous micro-and nano-suspensions of the enteric polymer Eudragit S100. High-pressure homogenisation was employed to produce nano-suspensions of the enteric polymer. Formed enteric suspensions (micro-and nano-) were evaluated in terms of size, morphology, and ability to form film; with resultant films analysed in terms of; film thickness, mechanical and thermoplastic properties, water uptake, weight loss, and drug permeability in acidic medium. High-pressure homogenisation yielded particles within a submicron range (150-200 nm). Produced nano-suspensions formed significantly thinner films (p < 0.01), at lower plasticiser concentrations, than films cast from micro-suspensions (differences in thickness up to 100 mm); however, exhibited comparative gastro-resistant properties (p > 0.05) in terms of water uptake ($25% w/w), weight loss (<16% w/w) and drug permeability (<0.1%). Interestingly, nano-suspension-based films exhibited lower glass transition temperatures (Tg) (p < 0.01), when compared to films cast from micro-suspensions ($7-20 C difference), indicating enhanced plasticisation. This was reflected in film mechanical properties; where nano-suspension-based films demonstrated significantly lower tensile strength (p < 0.01) and higher percentage elongation (p < 0.05), suggesting high elasticity. Thinner, highly elastic films were formed from nano-suspensions, compared to films cast from micro-suspensions, exhibiting comparative properties; obviating the need for alkalinising agents and high concentrations of plasticiser.

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Formulation and Manufacturing of Solid Dosage Forms

Cited by 9 publications

References 18 publications

Optimization of Pregelatinized Taro Boloso‐I Starch as a Direct Compression Tablet Excipient

Optimization of Pregelatinized Taro Boloso‐I Starch as a Direct Compression Tablet Excipient

Comparative Direct Compression Property of a Novel Pregelatinized Starch in Paracetamol Tablets

Impact of nanosizing on the formation and characteristics of polymethacrylate films: micro- versus nano-suspensions

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