THE TECHNOLOGY OF THE XSTRAW®? HOW DOES THE DEVICE WORK?

Very often, drugs are administered orally in the form of a tablet (in all variations) or a hard or soft capsule respectively. Everybody who has swallowing difficulties for whatever reason is longing for an easy yet effective drug delivery opportunity. A lot of developments are done or under way with orally dispersible forms (e.g. oral film or sublingual tablets), however, the pharma- codynamics (and thus also the pharmacokinetics) are very much dependent on the route of administration. In many cases, the same route is preferable than already designed in the form of a tablet or capsule. Here, the XStraw® offers a smart solution, especially for children and elderly people. And finally for everybody who wants it the easy way.

Pellets or granules containing the active ingredient, in most cases with a taste-masking in form of a coating, in some cases with an (additional) enteric coating, are delivered in form of an oral suspension to the stomach and the GI tract. The pellets / granules are contained in a drinking straw, which can be used with the most favorable drink and therefore are very easy to swallow. The patient can hardly feel that solid particles are swallowed. Taste only derives from the drink but none from the medicine.

That is also a clear advantage over oral suspensions.

 

 

DRUGS WHICH CAN BE FILLED INTO THIS DRUG DELIVERY DEVICE?

In principal, all products that can be formulated as solid multi-particulates (pellets or granules) are possible in the XStraw® as long as certain physical parameters are within a range most important: particle size distribution within 250 – 710 μm with a low content of fines; The multi-particulates must not be to soft;

There is no limitation in the diversification of API and products, however, the product needs to have a certain value simply because the drug delivery device adds to the cost and if price is the only means of diversification just let it be...please refer to cost and pricing.

Not only pharmaceutical but also nutraceutical and all kind of healthcare products are well administered with the XStraw®

SELECTION OF POSSIBLE DRUGS TO BE FILLED INTO THIS DRUG DELIVERY DEVICE

  • HIV (human immunodeficiency virus)
  • hepatitis B
  • hepatitis C
  • phenylketonuria / BH-4 deficiency
  • pulmonary hypertension
  • bacterial infections
  • prophylaxis CMV disease after organ transplantation
  • schizophrenia
  • leukemia
  • urea storage disorder
  • subependymal giant astracytoma due to tuberous sclerosis
  • epilepsy
  • cystic fibrosis
  • ulcerative colitis
  • Iron overload in thalassemia (including sickle cell anemia)
  • muscle relaxant
  • high blood pressure
  • ADHD
  • malaria (also prevention)
  • cholesterol
  • travelers' diarrhea
  • hay fever, allergies, hives / allergic rhinitis
  • prevention organ rejection after transplantation
  • reflux disease (stomach acid)
  • homocystinuria
  • lennox-gastaut-Syndrom
  • pain
  • depressions
  • essence. thrombocythemia
  • tyrosinemia type I
  • obesity
  • arthritis
  • type 2 diabetes
  • leishmaniasis (Kala Azar)
  • morbus wilson
  • fungal infections
  • nausea (e.g., chemotherapy)
  • acetylglutamate synthase deficiency
  • asthma

WHICH ACTIVE INGREDIENTS CAN YOU CURRENTLY PROVIDE TO BE FILLED IN THE XSTRAW®?

Currently there are proven formulations for 3 antibiotics: Clarithromycin, amoxicillin / clavulanic acid (7 : 1) and cefpodoxime. These products have already been available in XStraw® on the European and South American markets.

Available from 2019 onwords, newly formulated antibiotics from Hisun, China. Likewise a pharmacutical company based MENA region started to develop formulation for the following indications: HCV, Multiple Sclerosis, Sickle Cell, Anemia, Alzheimer disease.

WILL YOU ALSO FILL XSTRAW® WITH SPECIFIC PRODUCTS?

We do not plan to develop our own DS TECHNOLOGY products. We assist our customers and companies in developing their products – and, as partners, provide support along the entire process chain according to individual wishes and requirements.

From brainstorming to the project study, to the machine design, manufacturing and the production and logistics chain. For existing originator products, which have not been developed for the XStraw® and therefore are not in the form of pellets, it may be possible to develop an optimized particle size distribution for the XStraw®.

DEVICE & PRODUCT

Device considerations

  • Device was tested for use with children from 2 years on within clinical trial („DoSeiT Study“)
  • Device was tested concerning fluid mechanics (pressure drop and sucking profile) by children from 1,5 years on during development
  • Device was tested concerning child safety (holes in the cap to avoid suffocation etc.)

Product considerations

  • Best possible palatability
  • Best possible taste-masking
  • Yet, reasonable effort in manufacturing the multi-particulates for economic reasons
  • Long shelf-life beyond 24 months

 

 

 

ARE THERE ANY SPECIAL FEATURES?

There are holes situated in the top part due to an EN/DIN standard for children’s toys. Should children swallow the cap, the air holes prevent choking.

This was also tested in the past with Grünenthal by a Nuremberg institute. Furthermore there is an “olive” inside the cap, which guarantees the cap’s locking in place onto the shaped straw and thus a reliable closure.

WHAT ARE THE MATERIALS OF THE COMPONENTS OF THE XSTRAW® MADE?

Polypropylen (food grade approved)

 

 

 

WHAT ABOUT THE CONTROL FILTER?

1. Closure located at the bottom of the straw, pellets cannot fall out

2. Prevents the penetration of liquids into the straw from the bottom when placing it into the beverage; dissolving of the pellets is avoided (coating remains intact).

3. The liquid penetrates the control filter when suction is applied. Its structure changes (pores open). This is how the pellets are mixed/dispersed and conveyed into the patient with the flow of liquid. The patient then swallows the pellets together with the liquid. The control filter also moves upwards with the flow of liquid and remains in position.

4. Control function: After pellet intake, the control filter remains in the mouthpiece area of the straw – indicating the patient’s drug consumption to the parents/caregiver.

DO YOU SELL THE TECHNOLOGY (FILLING MACHINES) OR DO YOU ALSO SUPPLY FILLED XSTRAW®?

We organize the supply changefor the components (caps, straws, filters) for production, and you can then fill the product on-site or at a contract manufacturer of your choice.

WHAT IS THE TYPICAL SHELF-LIFE OF PRODUCTS FILLED INTO THE XSTRAW®?

The former owner of the IP rights performed stability tests with the result of a shelf-life of minimum 24 months for its antibiotics
Since a desiccant cap is possible even moisture sensitive products can be stored for this period
We assume that the shelf-life is the same as for the corresponding tablet or capsule formulation
Besides silicagel as a standard desiccant, molucular sieves can also be formulated in the cap material in order to have the hightest possible moisture extractio
In case of oxygen-sensitive products, nitrogen flushing can be applied on the packing machine to replace oxygen from the air in a pouch or stick-pack

HOW TO MANUFACTURE THE XSTRAW®?

DST_LS , output:
 
  • approx. 800,000 / a (single shift operation)
  • dosing amount 100-1.400 mg/XStraw® (higher and lower drug loads to be tested)
  • dosing by vacuum dosator

 

 

  • Timeline:
  • From PO to operation approx.
  • 6 months
DST_HS , output:
 
  • approx. 15 – 20 million / a (single shift operation)
  • dosing amount 100-1.400 mg/XStraw® (higher and lower drug loads to be tested)
  • dosing by vacuum dosator

 

  • Operation:
  • Fully automatic, one operator for assembly, filling and pouching process is enough

 

  • Timeline:
  • From PO to operation approx.
  • 12 months

DIFFERENCES TO COMPETITOR STRAW PRODUCTS

Main difference is the working principle!

Our XStraw® delivers multi-particulates (= product based on pellets or granules) as solid dispersion which does not dissolve during intake. Release of the API(s) is similar to a coated tablet or a hard capsule.

All other products in any straw – type device must dissolve during intake, otherwise the product doesn’t work. This is similar to a orodispersible tablet or an orodispersible film.