Selected Projects
From Scientific Research to Product Development
Midodrine Hydrochloride Low-Dose Pellet Formulation Development
We developed a low-dose oral pellet formulation of Midodrine Hydrochloride in 5 mg and 10 mg strengths. The project included formulation development, geometric dilution, wet granulation, extrusion–spheronization, fluid-bed drying, particle size classification, HPMC film coating, and capsule filling. The developed pellets were optimized to achieve suitable physical properties, consistent drug content, reliable dose uniformity, and immediate-release performance, providing a reproducible multiparticulate dosage form for low-dose oral administration.
Bilayer Acetaminophen 650 mg Tablet Formulation Development
We developed a bilayer Acetaminophen 650 mg tablet combining an immediate-release (IR) layer containing 325 mg of Acetaminophen with an extended-release (ER) layer containing 325 mg. The formulation development involved optimization of the composition and manufacturing parameters of each layer to achieve appropriate tablet properties and controlled drug-release performance. The developed bilayer system was designed to provide an initial immediate release followed by sustained release of Acetaminophen, combining rapid drug availability with prolonged release in a single dosage form.
Dapagliflozin 5 mg / Metformin 1000 mg Extended-Release Film-Coated Tablet Development
We developed a fixed-dose combination film-coated tablet containing 5 mg of Dapagliflozin and 1000 mg of Extended-Release Metformin. The formulation development focused on designing a robust matrix system for controlled release of Metformin while maintaining the required pharmaceutical properties of the combination tablet. Development activities included optimization of the formulation composition and manufacturing parameters, with emphasis on tablet quality, drug-content consistency, and reproducible extended-release performance.
Dapagliflozin 5 mg / Metformin 850 mg Immediate-Release Film-Coated Tablet Development
We developed a fixed-dose combination film-coated tablet containing 5 mg of Dapagliflozin and 850 mg of Metformin with an immediate-release profile. The formulation development focused on achieving uniform distribution of both active pharmaceutical ingredients, suitable compression and tablet characteristics, and consistent drug-release performance. The formulation and manufacturing process were optimized to provide a robust, reproducible oral dosage form with reliable quality and batch-to-batch consistency.
Dapagliflozin 5 mg & 10 mg Film-Coated Tablet Formulation Development
We developed film-coated tablet formulations of Dapagliflozin in 5 mg and 10 mg strengths, focusing on formulation design, powder processing, tablet compression, and film-coating development. The formulation was optimized to achieve consistent tablet weight, mechanical integrity, uniform drug content, and suitable dissolution characteristics across both dosage strengths. The development process resulted in reproducible tablet formulations with consistent pharmaceutical quality and suitability for further manufacturing scale-up.
Telmisartan 20 mg, 40 mg & 80 mg Film-Coated Tablet Formulation Development
We developed film-coated tablet formulations of Telmisartan in 20 mg, 40 mg, and 80 mg strengths, with a focus on formulation optimization and dose proportionality across the three strengths. The development process addressed powder processing, tablet compression, and film coating to achieve consistent tablet quality, uniform drug content, and suitable dissolution characteristics. The formulations were optimized to provide reproducible manufacturing performance and consistent pharmaceutical properties across all three dosage strengths.
Telmisartan / Hydrochlorothiazide Bilayer Film-Coated Tablet Formulation Development
We developed bilayer film-coated fixed-dose combination tablets of Telmisartan and Hydrochlorothiazide in three strengths: 40/12.5 mg, 80/12.5 mg, and 80/25 mg. The formulation was designed with Telmisartan and Hydrochlorothiazide incorporated into separate layers, allowing independent optimization of each layer while maintaining the required performance of the combined dosage form. Development activities included optimization of layer composition, powder processing, compression parameters, interlayer integrity, and film coating to achieve consistent tablet quality, drug-content uniformity, and reproducible dissolution performance across all three strengths.
L-Carnitine 1000 mg / L-Arginine 1000 mg Oral Solution
We developed an oral liquid formulation containing 1000 mg of L-Carnitine and 1000 mg of L-Arginine per vial. The formulation development focused on optimizing the aqueous composition, solubility, physical stability, taste characteristics, and compatibility of the two active ingredients. The manufacturing process was developed to obtain a uniform and stable oral solution with consistent active-ingredient content, suitable for filling into single-dose vials.
Cetirizine 10 mg Film-Coated Tablet Formulation Development
We developed a 10 mg film-coated tablet formulation of Cetirizine, focusing on formulation optimization, tablet manufacturability, and the application of a suitable film-coating system. The formulation was developed to achieve appropriate physical and mechanical tablet properties, uniform drug content, and consistent pharmaceutical performance, resulting in a robust and reproducible oral dosage form.
Metformin 500 mg Film-Coated Tablet Formulation Development
We developed and optimized a 500 mg film-coated Metformin tablet formulation, addressing the challenges associated with the high drug load and tablet manufacturing process. The development work focused on achieving suitable powder flow and compression characteristics, consistent tablet weight and mechanical strength, and an effective film-coating process. The final formulation provided a uniform, stable, and reproducible tablet suitable for further pharmaceutical development and scale-up.
Midodrine Hydrochloride API Synthesis & Process Optimization
We developed and optimized a multi-step synthetic process for Midodrine Hydrochloride starting from commercially available glycine. The development involved establishing and optimizing the key synthetic steps, reaction conditions, solvent systems, and operational parameters to improve reaction efficiency, reproducibility, yield, and scalability. The process was further evaluated through structural characterization of the intermediates and final API, resulting in a robust and reproducible synthetic route with potential for scale-up and industrial application.
Rivastigmine Tartrate API Enantioselective Synthesis & Process Development
We developed an efficient and enantioselective synthetic process for (S)-Rivastigmine Tartrate using ultrasonic irradiation and nano-K₂CO₃ as a catalytic system. The four-step synthetic route was developed using readily available and cost-effective starting materials, with optimization of the reaction conditions to achieve improved reaction efficiency, reduced reaction time, and minimized by-product formation. The developed process provided (S)-Rivastigmine Tartrate with an overall isolated yield of 83%, demonstrating a concise, reproducible, and resource-efficient approach for pharmaceutical API synthesis.