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US4029757A Expired / Lapsed US ⏱️ 0.0 years remaining

Manufacture of pharmaceutical unit dosage forms

Assignee: Hoffmann La Roche Inc
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Filing: 1975-12-15
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Granted: 1977-06-14
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Expires: 1995-12-15
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Abstract

Abstract Pharmaceutical dosage forms comprising an edible web having deposited thereon or at least partially thereon a particulate medicament, the webs being thereafter fabricated and finished to pharmaceutically elegant solid dosage forms having no medicament exposed on an exterior surface. The dosage forms have a consistency of release of medicament which can be controlled to exacting specifications. The disclosed solid dosage forms are prepared by high speed automated equipment and the process by which they are made is characterized by non-destructive quality control analysis and performance evaluation both conducted on-line and integrated into the manufacturing operation. Included in the scope of the disclosed invention are certain apparatus and methods of manufacture.

Inventors

  • 👤 Arthur Roman Mlodozeniec
  • 👤 Lawrence Samuel White

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-24 20:35
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2072; A61J; A61J3/00; A61K9/2095; A61K9/28; A61K9/70; A61F; A61F13/00; A61F13/02; A61F13/0276; A61F2013/0296; Y; Y10; Y10T; Y10T156/00; Y10T156/10; Y10T156/1002; Y10T156/1007; Y10T156/1015; Y10T156/1051; Y10T156/12; Y10T156/125

Claims Analysis

Total Claims: 5
Claim 1
Independent Claim 134 words
A method of preparing solid pharmaceutical unit dosage forms comprising loading one or more medicaments to a therapeutically inert, edible web, fabricating said web into a solid geometric form of predetermined dimensions having said medicament substantially internalized, said form being divisible into a plurality of unit dosage forms, unitizing said geometric form into said plurality of unit dosage forms and sealing said unit dosage forms to completely internalize said medicament wherein said procedures include at least one non-destructive testing operation to assure uniform quality of said unit dosage forms, wherein said fabrication procedure comprises fan folding a continuous web structure comprising at least one pair of layers of web having medicament loaded to the facing surfaces thereof and subjecting said stack to pressure to densify and shape same into a continuous rod-like geometric form.
Claim 2
Independent Claim 134 words
A method of preparing solid pharmaceutical unit dosage forms comprising loading one or more medicaments to a therapeutically inert, edible web, fabricating said web into a solid geometric form of predetermined dimensions having said medicament substantially internalized, said form being divisible into a plurality of unit dosage forms, unitizing said geometric form into said plurality of unit dosage forms and sealing said unit dosage forms to completely internalize said medicament wherein said procedures include at least one non-destructive testing operation to assure uniform quality of said unit dosage forms, wherein said fabrication procedure comprises fan folding a continuous web structure comprising at least one pair of layers of web having medicament loaded to the facing surfaces thereof and subjecting said stack to pressure to densify and shape same into a continuous rod-like geometric form.
Claim 3
Dependent Claim 99 words
A method in accordance with claim 1 wherein said unit dosage forms are sealed and unitized by: a. placing them in perforations of cooperating shape within an endless web strap comprised of therapeutically inert, edible material; b. placing said web strap between two endless webs comprised of therapeutically inert, edible material and sealing said webs to said unit dosage form-containing strap thereby forming a sandwich structure completely internalizing said unit dosage forms; and c. transversely cutting said sandwich structure between said perforations of said perforated strap such that exposure of any part of said unit dosage forms is avoided.
Claim 4
Dependent Claim 48 words
A method in accordance with claim 2 wherein said strap has a thickness equal to or greater than x and not greater than y wherein x is approximately 1/2 of the thickness of said unit dosage forms and y is approximately the thickness of said unit dosage forms.
Claim 5
Dependent Claim 139 words
A method in accordance with claim 1 wherein said unit dosage forms are sealed and unitized by: a. placing them in perforations of cooperating shape within an endless web strap comprised of therapeutically inert, edible material, which endless perforated strap is secured initially to a first endless unperforated web comprised of therapeutically inert, edible material of comparable dimensions to said perforated web strap so as to form said perforations into bottomed receptacles for receiving said unit dosage forms; b. covering the open portion of said receptacles with a portion of a second endless unperforated web comprised of therapeutically inert, edible material; c. sealing said second web to said receptacles thereby completely internalizing said unit dosage forms; and d. transversely cutting said sealed strap between said perforations such that exposure of any part of said unit dosage forms is avoided.

References Cited (Backward Citations)

US2836291A Cited
US3007848A Cited
US3917255A Cited
US3917251A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1980-06-13 1980-12-13 1981-06-14 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1984-06-13 1984-12-13 1985-06-14 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1988-06-13 1988-12-13 1989-06-14 $7700.00 Window Closed / Lapsed

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