Spray Drying for Direct Compression of Pharmaceuticals

Al-Zoubi, Nizar; Gharaibeh, Shadi F.; Aljaberi, Ahmad; Nikolakakis, Ioannis

doi:10.3390/pr9020267

Cited by 35 publications

(13 citation statements)

References 114 publications

(158 reference statements)

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“…Table 3 presents the advantages and limitations of each co-processing technique. 42,[45][46][47][48]…”

Section: Co-processed Excipientsmentioning

confidence: 99%

Application of co-processed excipients for developing fast disintegrating tablets: A review

Jain¹,

Kaur²,

Rathi³

et al. 2023

Polim. Med.

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The introduction of tablet dosage forms has brought a revolution in the pharmaceutical drug delivery system. Different forms of tablets have been developed based on the target site, the onset of action, and therapeutic drug delivery methods. Fast-disintegrating tablets (FDTs) are the most promising pharmaceutical dosage form, especially for pediatric and geriatric patients having difficulty swallowing. The key feature of FDTs is quick drug release soon after their administration through the oral cavity. With innovations in the formulation of FDTs, the demand for excipients with better functionalities, particularly in terms of flow and compression characteristics, has increased. Co-processed excipients are a mixture of 2 or more conventional excipients that provides significant benefits over the individual excipients while minimizing their shortcomings. Such multifunctional co-processed excipients minimize the number of excipients that are to be incorporated into tablets during the manufacturing process. The present review discusses FTDs formulated from co-processed excipients, their manufacturing techniques, and the latest research, patents and commercially available co-processed FDTs.

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“…Table 3 presents the advantages and limitations of each co-processing technique. 42,[45][46][47][48]…”

Section: Co-processed Excipientsmentioning

confidence: 99%

Application of co-processed excipients for developing fast disintegrating tablets: A review

Jain¹,

Kaur²,

Rathi³

et al. 2023

Polim. Med.

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“…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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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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“…Smaller particle sizes have a larger surface area that increases dissolution rate, which can improve bioavailability [17]. However, smaller particle sizes can cause manufacturing challenges through reduced particle compressibility and poor flow properties, increasing the risk of particle segregation and compressibility adversely affecting final dosage form qualities, such as content uniformity and tablet hardness [18,19]. Substantial experimentation is required to co-optimize formulation and process parameters to define the multivariate relationships for a SDD formulation [20,21].…”

Section: Introductionmentioning

confidence: 99%

Predicting Spray Dried Dispersion Particle Size Via Machine Learning Regression Methods

Schmitt¹,

Baumann

Morgen

2022

Pharm Res

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Spray dried dispersion particle size is a critical quality attribute that impacts bioavailability and manufacturability of the spray drying process and final dosage form. Substantial experimentation has been required to relate formulation and process parameters to particle size with the results limited to a single active pharmaceutical ingredient (API). This is the first study that demonstrates prediction of particle size independent of API for a wide range of formulation and process parameters at pilot and commercial scale. Additionally we developed a strategy with formulation and target particle size as inputs to define a set of “first to try” process parameters. An ensemble machine learning model was created to predict dried particle size across pilot and production scale spray dryers, with prediction errors between −7.7% and 18.6% (25th/75th percentiles) for a hold-out evaluation set. Shapley additive explanations identified how changes in formulation and process parameters drove variations in model predictions of dried particle size and were found to be consistent with mechanistic understanding of the particle formation process. Additionally, an optimization strategy used the predictive model to determine initial estimates for process parameter values that best achieve a target particle size for a provided formulation. The optimization strategy was employed to estimate process parameters in the hold-out evaluation set and to illustrate selection of process parameters during scale-up. The results of this study illustrate how trained regression models can reduce the experimental effort required to create an in-silico design space for new molecules during early-stage process development and subsequent scale-up.

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Spray Drying for Direct Compression of Pharmaceuticals

Cited by 35 publications

References 114 publications

Application of co-processed excipients for developing fast disintegrating tablets: A review

Application of co-processed excipients for developing fast disintegrating tablets: A review

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

Predicting Spray Dried Dispersion Particle Size Via Machine Learning Regression Methods

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