Design of Experiments for Critical Material Attributes Assessment of Linagliptin and Metformin Fixed-dose Combination Tablets

Kim, Kang Min

doi:10.5530/ijper.55.3.142

Cited by 3 publications

(2 citation statements)

References 15 publications

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“…The contour plot representing the relation of selected responses with the variables gives the variance effects. RSM was used to determine and elucidate the response of individual parameters over the different responses attained [46,47]. Three-dimensional surface graphs are essential to demonstrate the interactions and main effects.…”

Section: Selection Of Anti-adhesive Additives and Optimization Of Ih-ufmentioning

confidence: 99%

Development of Novel Unfolding Film System of Itopride Hydrochloride Using Box-Behnken Design—A Gastro Retentive Approach

Alaithan

Naveen²,

Goudanavar³

et al. 2022

Pharmaceuticals

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Currently, gastro-retentive dosage forms achieved a remarkable position among the oral drug delivery systems. This is a broadly used technique to hold the drug delivery systems for a long duration in the gastro intestine (GI) region, slow drug delivery, and overcome other challenges related to typical oral delivery such as low bioavailability. The current work aimed to formulate and characterize a new expandable gastro-retentive system through Itopride Hydrochloride (IH)’s unfolding process for controlled release. The IH-loaded unfolding film formulation was optimized using the Box-Behnken design for folding endurance and length of tested layer (LTL). Initially, the formulation was made using several anti-adhesive additives to promote the unfolding mechanism. Citric acid and sodium bicarbonate were selected as anti-adhesives based on these results. The enfolded film in a capsule shell was shown to unroll in the stomach fluids and render drug delivery up to 12 h in acidic conditions. A fabricated system should have dimensions more than the size of the relaxed pyloric sphincter, and as required, >20 mm LTL was identified. This further confirms that the residence period in the stomach is irrelevant to the fed or fasted condition. Based on desirability criteria, the formulation containing 143.83, 0.7982, and 14.6096 Eudragit L100, PEG, and sodium bicarbonate are selected as optimized formulations (O-IH-UF). The optimized formulation was further analyzed for various parameters such as tensile strength, mechanical strength, unfolding nature, degradability, and in vitro release studies. The pharmacokinetic study revealed greater AUC (area under the curve) and long half-life with the designed O-IH-UF formulation, confirming that the unfolding film type can be a favorable drug system for enhancing the bioavailability of low soluble drugs. The results showed that unfolding types of gastro retentive systems could potentiate the drugs with stability issues in an alkaline medium or those with absorption in acidic conditions.

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Section: Selection Of Anti-adhesive Additives and Optimization Of Ih-ufmentioning

confidence: 99%

Development of Novel Unfolding Film System of Itopride Hydrochloride Using Box-Behnken Design—A Gastro Retentive Approach

Alaithan

Naveen²,

Goudanavar³

et al. 2022

Pharmaceuticals

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show abstract

“…The model was fitted after performing the experimental runs by incorporating the responses. The RSM statistical design based on the BBD design is advantageous over the typical method to optimize the several critical factors for the proposed study to estimate their influences [ 35 , 36 , 37 ].…”

Section: Introductionmentioning

confidence: 99%

Development of Nanocrystal Compressed Minitablets for Chronotherapeutic Drug Delivery

Sreeharsha

Naveen²,

Anitha³

et al. 2022

Pharmaceuticals

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The present work aimed to develop a chronotherapeutic system of valsartan (VS) using nanocrystal formulation to improve dissolution. VS nanocrystals (VS-NC) were fabricated using modified anti-solvent precipitation by employing a Box–Behnken design to optimize various process variables. Based on the desirability approach, a formulation containing 2.5% poloxamer, a freezing temperature of −25 °C, and 24 h of freeze-drying time can fulfill the optimized formulation’s requirements to result in a particle size of 219.68 nm, 0.201 polydispersity index, and zeta potential of −38.26 mV. Optimized VS-NC formulation was compressed (VNM) and coated subsequently with ethyl cellulose and HPMC E 5. At the same time, fast dissolving tablets of VS were designed, and the best formulation was loaded with VNM into a capsule size 1 (average fill weight—400–500 mg, lock length—19.30 mm, external diameter: Cap—6.91 mm; Body—6.63 mm). The final tab in cap (tablet-in-capsule) system was studied for in vitro dissolution profile to confirm the chronotherapeutic release of VS. As required, a bi-pulse release of VS was identified with a lag time of 5 h. The accelerated stability studies confirmed no significant changes in the dissolution profiles of the tab in cap system (f2 similarity profile: >90). To conclude, the tab in cap system was successfully developed to induce a dual pulsatile release, which will ensure bedtime dosing with release after a lag-time to match with early morning circadian spikes.

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Exploring Magnesium Myristate for Its Dual Functionality as a Binder and Lubricant in the Formulation of Tablet

Pockle,

Masareddy,

Bambulkar

et al. 2024

Ther. Deliv.

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Purpose: To explore ‘magnesium myristate’ for its dual functionality as a lubricant and binder in the formulation of tablets. Methods: Using (DoE), tablet formulations using magnesium myristate and conventional excipients (magnesium stearate and PVP K30) were developed by wet granulation technique. The prepared granules and formulated tablets were evaluated for pre- and post-compression parameters, respectively. Results: Magnesium myristate exhibited excellent flow properties. The optimized formulations containing magnesium myristate exhibited increased hardness and in vitro drug release in comparison to conventional excipients. f2 similarity index for in vitro drug release showed no significant variations with optimized formulations and with the marketed formulations. Conclusion: Magnesium myristate shows a promising replacement for conventional excipients as both a lubricant and binder in tablet formulation.

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Design of Experiments for Critical Material Attributes Assessment of Linagliptin and Metformin Fixed-dose Combination Tablets

Cited by 3 publications

References 15 publications

Development of Novel Unfolding Film System of Itopride Hydrochloride Using Box-Behnken Design—A Gastro Retentive Approach

Development of Novel Unfolding Film System of Itopride Hydrochloride Using Box-Behnken Design—A Gastro Retentive Approach

Development of Nanocrystal Compressed Minitablets for Chronotherapeutic Drug Delivery

Exploring Magnesium Myristate for Its Dual Functionality as a Binder and Lubricant in the Formulation of Tablet

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