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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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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Factors Influencing Drug Absorption: Drug Dissolution01:27

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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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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,...
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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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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...
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Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
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Solid-State Stability of Pentobarbital in Fast-Dissolving Suppositories: Implications for Dissolution Behavior and

Aurélien Freisz1, Imen Dhifallah2, Philip Chennell3

  • 1CHU Clermont-Ferrand, Pôle Pharmacie, 63003, Clermont-Ferrand, France.

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Summary

Frozen storage is crucial for maintaining the stability of pentobarbital suppositories for pediatric sedation. This ensures the drug remains dissolved and effective for procedural care, unlike refrigerated storage which causes precipitation.

Keywords:
formulationpediatricspentobarbitalsedationstabilitysuppositories

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Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Pharmacology
  • Formulation Stability

Background:

  • Safe and effective sedative formulations are vital for pediatric procedural care.
  • Pentobarbital is a widely used pediatric sedative, but oral administration is limited by palatability.
  • Rectal administration of pentobarbital suppositories offers an alternative if formulation stability is assured.

Purpose of the Study:

  • To evaluate the physicochemical and microbiological stability of fast-dissolving pentobarbital suppositories for pediatric use.
  • To determine the impact of storage conditions (refrigerated vs. frozen) and sodium hydroxide (NaOH) concentration on suppository stability.
  • To assess the long-term preservation of pentobarbital sodium in suppository form.

Main Methods:

  • Formulation of pentobarbital sodium suppositories with varying NaOH concentrations.
  • Storage of suppositories at 5°C (refrigerated) and -20°C (frozen) for up to 180 days.
  • Assessment of stability via macroscopic examination, pH, dissolution, mechanical strength, softening time, microbiological quality, Raman spectroscopy, and X-ray diffraction.

Main Results:

  • Refrigerated storage (5°C) induced pentobarbital precipitation, pH decrease, and conversion to free acid, leading to incomplete dissolution after 90 days.
  • Frozen storage (-20°C) maintained suppository integrity, pH, and complete dissolution throughout the study period.
  • Frozen suppositories remained stable even after thawing and subsequent 30-day storage at 5°C; increased NaOH delayed but did not prevent instability at 5°C.
  • All formulations met pharmacopeial mechanical and microbiological standards.

Conclusions:

  • Storage temperature is the primary factor influencing pentobarbital suppository stability, with freezing ensuring long-term preservation.
  • Sodium hydroxide buffering helps mitigate formulation issues and delays drug degradation, extending shelf life.
  • These findings support further development and clinical evaluation of pentobarbital suppositories for pediatric sedation.