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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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...
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Liddle syndrome is a genetically inherited form of hypertension characterized by the overactivity of epithelial sodium channels in the nephron, the functional unit of the kidney. This heightened activity leads to increased sodium reabsorption and excessive excretion of potassium. To counteract this, potassium-sparing diuretics such as amiloride are used. They function by blocking these sodium channels, thereby reducing the influx of sodium into the epithelial cells and minimizing the loss of...
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Thiazide diuretics are sulfonamide derivatives featuring a benzothiadiazine ring system in their molecular structure. Based on this structure, thiazide diuretics can be categorized into two groups: thiazide-type and thiazide-like diuretics. Thiazide-type diuretics, including hydrochlorothiazide and chlorothiazide, consist of a benzothiadiazine backbone with an attached sulfonamide group. Thiazide-like diuretics, such as chlorthalidone and indapamide, lack the thiazide ring but demonstrate...
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The renin-angiotensin-aldosterone system (RAAS) is an intricate physiological pathway involving numerous enzymes and hormones, including renin, angiotensin-converting enzyme (ACE), angiotensin I and II, and aldosterone. Imbalances within this system increase the production of angiotensin II and aldosterone. Increased angiotensin II levels promote vasoconstriction and blood pressure elevation. Concurrently, higher aldosterone levels stimulate sodium and water reabsorption in the kidneys,...
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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Formation of Dispersible Taohong Siwu Tablets
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Hydrochlorothiazide/Losartan Potassium Tablet Prepared by Direct Compression.

Qiuhua Luo1,2, Qianying Zhang3, Puxiu Wang1,2

  • 1Department of Pharmacy, The First Affiliated Hospital of China Medical University, Shenyang 110001, China.

Pharmaceutics
|August 26, 2022
PubMed
Summary

This study optimized the formulation of hydrochlorothiazide (HCTZ) and losartan potassium (LOS-K) tablets using powder compression properties and experimental design. The resulting tablets showed comparable bioavailability to a commercial product.

Keywords:
D-optimal mixture experimental designbioavailibilitycompression and mechanical propertiesdirect compressiondissolution rate

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Pharmacokinetics

Background:

  • Developing fixed-dose combination tablets requires careful optimization of formulation and preparation parameters.
  • Understanding powder compression and mechanical properties is crucial for successful direct powder compression tablet manufacturing.

Purpose of the Study:

  • To optimize the formulation and preparation of hydrochlorothiazide/losartan potassium (HCTZ/LOS-K) compound tablets using direct powder compression.
  • To evaluate the bioavailability of the optimized HCTZ/LOS-K tablets compared to a reference product.

Main Methods:

  • Investigation of powder compression and mechanical properties (compressive work, stress relaxation, Py value).
  • Application of Kawakita, Shapiro, and Heckel analyses to understand powder compression mechanisms.
  • D-optimal mixture experimental design for formulation optimization based on dissolution rate.
  • Bioavailability study in beagle dogs comparing optimized tablets with Hyzaar®.

Main Results:

  • Lactose monohydrate, microcrystalline cellulose (MCC PH102), and pre-gelatinized starch were identified as key excipients with determined optimal ranges.
  • The mixed powder was classified as Class-II, with recommended compaction pressure and tableting speed.
  • An optimal formulation (No. 1) was selected based on dissolution rate.
  • No significant bioavailability differences were observed between the optimized tablets and Hyzaar® for HCTZ, E-3174, and LOS-K.

Conclusions:

  • Direct powder compression is a feasible method for preparing HCTZ/LOS-K compound tablets.
  • Combining powder mechanical properties analysis with experimental design effectively determines optimal formulation and preparation factors.
  • The optimized HCTZ/LOS-K tablets exhibit comparable bioavailability to the reference product, ensuring therapeutic equivalence.