Related Experiment Video
Updated: May 11, 2026
07:32
Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
Published on: August 28, 2015
Preparation, characterization and tableting of cilnidipine solid dispersions
Liandong Hu1, Weihua Song, Feng Niu
1College of Pharmaceutical Sciences, Hebei University, Baoding, China. hbupharm@126.com
Pakistan Journal of Pharmaceutical Sciences
|April 30, 2013
Summary
This study developed cilnidipine solid dispersions using polyethylene glycol (PEG) for improved solubility and oral bioavailability. An innovative granulation method simplified production, enhancing operability, stability, and dissolution for industrial applications.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Materials Science
Background:
- Solid dispersions enhance oral bioavailability of poorly soluble drugs.
- Traditional solid dispersion tableting presents large-scale production challenges.
- Cilnidipine is a water-insoluble drug requiring improved dissolution characteristics.
Purpose of the Study:
- To develop cilnidipine solid dispersions (SDs) to enhance dissolution behavior.
- To design an innovative granulation method for simplified tableting of SDs.
- To optimize SD formulations for improved industrial scalability.
Main Methods:
- Preparation of cilnidipine solid dispersions using polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), and poloxamer as carriers.
- Solid-state characterization using differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), and FT-IR spectroscopy.
- Development and application of a simplified granulation method for solid dispersion tablet preparation and optimization through dissolution studies.
Main Results:
- Polyethylene glycol (PEG) solid dispersions demonstrated superior physical characteristics and dissolution profiles.
- All prepared solid dispersions significantly enhanced cilnidipine dissolution rates compared to the pure drug and physical mixtures (PM).
- Tablets manufactured using the simplified granulation method exhibited improved operability, stability, and dissolution.
Conclusions:
- Solid dispersion technology, particularly with PEG, effectively improves cilnidipine's dissolution and bioavailability.
- The novel granulation method simplifies solid dispersion tableting, enhancing industrial production viability.
- This approach offers a promising pathway for the scalable manufacturing of solid dispersion formulations.
Related Concept Videos
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
01:13In Vitro Drug Dissolution: Compendial Testing Models I
Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
01:05Bioavailability Enhancement: Drug Stability Enhancement and GI Retention
Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...