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Oral Dosage Formulations

Among the many different formulations for finished pharmaceutical products, oral dosage forms remain the most convenient choice, coupled with the benefit that taking a medicine via the oral route is one of the easiest and best options for the patient.

Tablets and capsules are normally single-dose preparations which are intended to be either swallowed whole, chewed crushed, dissolved or dispersed in water before being taken. Many oral dosage units will contain one or more active ingredients and they may also contain excipients to act as diluents, binders, disintegrating agents or for modifying the behaviour of the dosage forms and the active ingredient(s) once inside the digestive tract.

Liquid preparations for oral use are usually solutions, emulsions or suspensions that contain one or more active ingredients in a suitable vehicle. Such preparations will contain suitable antimicrobial preservatives, antioxidants and other excipients to aid dispersion, suspension, stabilisation and flavouring amongst a number of other factors.

Parenteral products are liquid preparations administered directly into body tissues rather than via the oral route. “Parenteral” is itself derived from the Greek words para (beside) and enteron (the intestine) and most often refers to either subcutaneous (SC), intramuscular (IM), or intravenous (IV) administration of drugs. Liquid preparations administered by injection are characterised by three qualities possessed by no other type of pharmaceutical dosage form: sterility, freedom from pyrogens, and particulate matt.

At Tepnel, we have over 30 years of experience in the quality control testing of the most common forms of oral dosage and parenteral formulations;

  1. Tablets
  2. Capsules
  3. Oral suspensions
  4. Emulsions
  5. Lozenges
  6. Liquid and lyophalised vials for injection

Testing and techniques available for batch release testing include:

Tablets/Capsules Oral Suspensions Parenteral Products
Size, shape, appearance Colour, clarity Identification of active ingredient(s)
Organoleptics pH pH
Weight uniformity Viscosity Extractable volume
Content uniformity Active content Particle count
Dissolution (paddle and basket) Related substances Pyrogen / LAL
Hardness Preservatives Sterility
Friability Total microbial count Effectiveness of microbial preservatives
Active content Limit test for degradation products/ impurities
Related substances Assay of active ingredient (s)
Disintegration
Total viable count
Moisture content

Sections in Batch Release Services

All Batch Release Services

Additional Resources

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