Novel formulation preparations

• Suppository

  A drug delivery system that is inserted either into the rectum, vagina or urethra where it dissolves
• Suppository

  • Used to deliver both systemically-acting and locally-acting medications
  • The general principle is that the suppository is inserted as a solid, and will dissolve inside the body to deliver the medicine
• Vaginal suppositories


  • Used to treat gynecological ailments, including vaginal infections such as candidiasis
• Rectal suppositories

  • Used for laxative purposes, with chemicals such as glycerin or bisacodyl
  • Used for treatment of hemorrhoids by delivering a moisturizer or vasoconstrictor
  • Used for delivery of many other systemically-acting medications, such as promethazine or aspirin
  • Used for general medical administration purposes: the substance crosses the rectal mucosa into the bloodstream; examples include paracetamol (acetaminophen), diclofenac, opiates, and eucalyptol suppositories
• Urethral suppositories

  • Alprostadil pellets are used for the treatment of severe erectile dysfunction, marketed under the name Muse in the United States
• The US government allocates billions of dollars every year through the Department of Health and Human Services (HHS), the Public Health Service (PHS), and the National Institutes of Health (NIH) to Support research aimed at understanding disease mechanisms and finding therapeutic solutions
• The drug industry also spends several billion dollars each year in pharmaceutical research to transform novel chemicals and biologics into medicinal that are safe and effective for human use
• To ensure that a new drug candidate is proved effective and safe before it reaches the US market


  All of the information that has been gathered about the new drug candidate is rigorously scrutinized by the Food and Drug Administration and by independent experts called upon to assist the agency in its evaluation
• Whether a drug candidate is a protein, nucleic acid, or small molecule, manufactured in the United States or abroad, the same regulations apply
• New drug application (NDA) process

  The process for reviewing traditional drugs (i.e., small organic molecules)
• Biologic license application (BLA) process


  The process for reviewing macromolecules (biopharmaceuticals), including proteins, peptides, genes, and recombinant products
• The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), within the FDA, have been responsible for the review of NDAs and BLAs, respectively
• The International Conference on Harmonization (ICH), which includes the FDA and its counterpart agencies in the European Union and Japan, was established in 1991 with the goal of increasing the efficiency of the drug approval process for the international marketplace
• The guidelines developed by the ICH have yet to be fully accepted in most nations
• While we recognize the importance of international licensing of drugs and biologics, we will focus on the drug development and approval process elaborated by the FDA for new molecular entities (NMEs), emphasizing the differences between traditional drugs and biopharmaceuticals