Hypoallergenic compounding

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Hypoallergenic compounding

• You cannot lie to an allergy patient
• von Dr. med. Siegfried Schlett Apotheker und Arzt

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Rewiev of industrial site

• Production on a high technical level
• Time is money
• Course of development needs much time and money.
  New compounds cannot be transformed into reality
  in short time
• Technical production has its own price in
  quality of products

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Industrial production

• Generate specific demands on raw materials as
  size of cristal structure, density, moisture and
  flowing properties
• Requires flowing agents to guarantee continously
  support of powder ore granules to be filled in
  capsules ore been pressed to tablets ore dragees.
• Requires additives to care for the machines
• Next page example for a typical multivitamine

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EU-guidelines for additives in nutrition and
nutrient formulars

• Colouring agents, preservatives, antioxidants,
  emulgators, melting salts, thickening and
  emulsifying agents, stabilisators, foam
  stabilisating agents, taste enhancing, acids,
  acid-regulating substances ,easy flow and taste
  masking, lubricants, binders, fillers,
  disintegrants, diluents, glaze (a shellac),
  sweeteners, wax, starch, coatings, foam
  protection, films, moistoring agents, metal
  containing soaps.

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The patients choice?

• He needs purest raw material and has to work out
  hidden lactose or allergenic fillers, which are
  not on the label of his product
• Standartized lactose-rub-in raw materials
  (digestive enzymes, Bromelain)
• No added preservatives means, there is no
  preservative added by the manufacturer, but the
  raw material...?
• If the product doesnt state Manufactured by on
  its label, it is made by a jobber. The presence
  of excipients might not even be known by the
  distributor

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Bio-energetic investigation

• The result of bio-energetic investigation is the
  sume of all details of your formular
• It is quite logic to test with clean formuars,
  you can count on
• Testing materials must be identic with
  therapeutic agents not only in its main acting
  substance, but also in the excipients.
• Pharmacies and manufacturers should compound in
  hypoallergenic manners

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Effects on environmental factors

• Excipients enriched (Magnesiumstearate)
  undigestable formulars carry pharmaceutical stuff
  into environmental surroundings.
• BGA 1996 Clofibrinic acid in underground water
  in Berlin (180ng/l)
• PZ 2001 17-ß-Estradiol imGerman rivers already
  on a level of 1,6ng/l
• Niedersachsen is observing the content of
  Tetracyclin in liquid manure excreted by animals
• Ärztezeitung 1.7.2003 antibiotic residues
  (Sulfametoxazol) im Bavarian drinking water

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Allergy patients

• Dramaticly increasing rate of allergic reacting
  children
• Asthma increased 33 (1995 - 2000) on to 12,5
• Pollinosis increased 29 (1995 - 2000) on to
  16,1
• 2006 even every forth child is an allergy patient
• Colouring agents and sulfits are dangerous to
  lung function. (J. Allergy Clin. Immun. 96 (1996)
  839-41
• Allergic reactions are the most registered site
  effects in all countries with departments for
  supervision of consumers reaction.

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Effects of exipients on pharmaceutical kinetics

• Metal-containing soaps (Magnesium-stearat and
  fatty acid compounds as Ascorbylpalmitate) often
  are used as excipients, which lubrify the filling
  material (production of tablets and dragees). The
  working machines do have a lubricant during their
  high speed actions. The surface of the tablets
  becomes shining.
• Consequences for digestion

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Compounding pharmacies

• New chelating compounds for trace elements or
  minerals, which are not available in industrial
  production are available through compounding
  pharmacies.
• New vitamin formulars as methylcobalamin (B12)
  can be produced quickly and in hypoallergenic
  manner, so the best investigations can be
  transported into the best form of therapy.
• compounding pharmacies, who know to handle with.
  Sterile manufacturing, are even qualified in this
  subjects. Klösterl-pharmacy developed a DMSA
  formular for interavenous use together with
  Dr.med max Daunderer, Tocxcenter München.

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AK promotes cooperation doctor-pharmacist

• Individual formulars are available in
  hypoallergenic quality
• Prescriptions are the comunicating billet.
• Recepies for substances under prescription
  (hormones) and not under prescription (vitamins).
• Pharmacist collects the recepies and shows, that
  his manufacuting activities are due to
  practitioners demand.

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Compounding pharmacies

• Compounding pharmacies buy proofed raw material
  and decide together with practitioners, what is
  the best joice for patients use.
• Guarantee independence of imports
• Improve dialogue between doctor and pharmacist
• Realize quickly new dveleopments in therapy
• Guarantee high level of quality for
  AK-practitioners and patients.